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From: Califchief on 6 Aug 2008 23:26
Di wrote:

> If Supartz is anything like Hyalgen, it will be a cake walk. I
> sure hope it works wonders for you. I'll be keeping my fingers
> crossed for ya! And, good luck with the surgeon. Keep us posted.

I went to the FDA's web site after reading Lou Jean's post about
Supartz. I had never heard of it before.

I didn't like what the FDA had posted about "injury," aka an
adverse/allergic reaction.

Luckily that gal worked in a hospital's emergency ward and
received prompt attention.



http://www.fda.gov/cdrh/pdf/p980044.html

SUPARTZT Dispo -- P980044

Issued January 24, 2001
Part 1 - Approval Order
Part 2 - Summary of Safety and Effectiveness
Part 3 - Labeling
Other Consumer Information
These documents are in a Portable Document Format (PDF). Acrobat Reader is
required to read this document.
============================================================================


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036773


Adverse Event Report

SEIKAGAKU CORPORATION SUPARTZ SODIUM HYALURONATE
Catalog Number 71567761
Event Date 04/11/2008
Event Type Injury Patient Outcome Other;
Event Description

Event; allergic reaction. In 2008 - the pt received her 1st dose of supartz
injections to her knees (bilaterally). After a few hrs, she returned to work
and started feeling nauseated and dizzy. After four hrs, her tongue began to
swell and she had difficulty breathing. She is a clerk at the local
emergency hosp, so she received medical attention from a resident medical
physician. Her tests reflected that she had edema around her heart as well.
The resident physician treated her for allergic reactions and gave her
benadryl and steroids. After the treatment, she was doing well. She thinks
because she has thyroid myalgia, her body reacted differently to the supartz
therapy. According to the injecting physician, she had multiple variables
during the time of the reaction, and it is indeterminate if the supartz was
actually responsible. Thyroid myalgia - symptoms are the same as those of
other conditions, such as chronic fatigue syndrome, under-active thyroid,
lyme disease, lupus, and multiple chemical sensitivity. It is diagnosed when
the others cannot. The pt had a suspicion that her reaction was related to
the disease; however, the physician does not share her opinion. He suspects
the infection was obtained through the injection site. The pt had bilateral
injections but only was affected in one of her knees. If the pt's disease
was a factor, it would have affected both knees. He stated variables such as
the swelling was isolated to one knee and not both, she had cortisone shots
the days before to both of her hips, she was not allergic to chicken
products, and the her signs and symptoms were not clinically evident upon
eval. Based upon these findings, he stated that it was indeterminate to the
actual cause of her reaction. As a precautionary measure, she was treated
with steroids and benadryl and is doing well. No further incidents were
reported.


Manufacturer Narrative
Our medical adviser suggested as follows: since this adverse event occurred
a few hrs after supartz injection, and the pt had difficulty breathing after
four hrs, it is considered to be hypersensitive reaction to supartz
injection, and causal relationship between the event and supartz injection
cannot be denied. However, it is difficult to consider the adverse event as
allergic reaction to supartz itself because supartz injection was the first
time for the pt. The injecting physician gave supartz injection to
bilateral knees, but swelling developed one of her knees, so he suspects
infection. The pt had steroid injection to her hips the days before, and it
is also suspected that she had latent infection preliminarily. The pt
reported to have complication of thyroid myalgia. It seems that thyroid
myalgia can cause a hypersensitive condition to multiple chemicals.
Considering the pt's condition, it is presumable the allergic reaction was
caused by injecting procedures-inducible components of bacteria or fungi.


Brand NameSUPARTZ
Type of DeviceSODIUM HYALURONATE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F) SEIKAGAKU CORPORATION
6-1, marunouchi 1-chome,
chiyoda-ku
tokyo
JAPAN 100-0005

Manufacturer (Section D) SEIKAGAKU CORPORATION
6-1, marunouchi 1-chome,
chiyoda-ku
tokyo
JAPAN 100-0005

Manufacturer (Section G) SEIKAGAKU CORPORATION
6-1, marunouchi 1-chome,
chiyoda-ku
tokyo
JAPAN 100-0005

Manufacturer Contactphillip emmert, ms, sr specialist
1450 brookd rd
memphis, TN 38116
(901) 399 -5296

Device Event Key1005853
MDR Report Key1036773
Event Key995144
Report Number9612392-2008-00003
Device Sequence Number1
Product CodeMOZ
Report SourceManufacturer
Source TypeHealth Professional
Reporter OccupationPhysician
Type of Report Initial
Report Date04/28/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2008
Is This An Adverse Event Report?Yes
Is This A Product Problem Report?No
Device OperatorHealth Professional
Device Catalogue Number71567761
Device LOT Number7C168N
Was Device Available For Evaluation?No
Is The Reporter A Health Professional?Yes
Was the Report Sent to FDA?No
Event LocationOther
Was The Report Sent To Manufacturer?No
Date Manufacturer Received04/16/2008
Was Device Evaluated By Manufacturer?Device Not Returned To Manufacturer
Date Device Manufactured03/01/2007
Is The Device Single Use?Yes
Is the Device an Implant?Yes
Is this an Explanted Device?
Type of Device UsageInitial

Patient TREATMENT DATA
Date Received: 04/28/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
1,TRADE NAME (GENERIC NAME),
2,ROUTE OF ADMIN,
3,DAILY DOSE,
4,INITIAL DATE & FINAL DATE OF ADMIN,
5,MOTRIN ,
6,BLOOD PRESSURE MEDICINE,

Database last updated on June 30, 2008


.... Tom's incompetence knows no barriers of country or newsgroup.
___ Blue Wave/QWK v2.12
From: Gloria Wolfe on 7 Aug 2008 15:11
Chief, I hadn't heard of that drug either, but I didn't follow through like you
did. Of course, Synvisc is the standard, and that is what I had. But, by that
time my knee was in too bad of shape to get any benefit at all. I should
have asked Navy, too, why the knee cap would prevent her from getting
surgery. It might just be my ignorance. Nanny

On 8/6/2008 10:26 PM, CALIFCHIEF wrote to ZINKYDI(a)GMAIL.COM:

-> Di wrote:
->
-> > If Supartz is anything like Hyalgen, it will be a cake walk. I
-> > sure hope it works wonders for you. I'll be keeping my fingers
-> > crossed for ya! And, good luck with the surgeon. Keep us posted.
->
-> I went to the FDA's web site after reading Lou Jean's post about
-> Supartz. I had never heard of it before.
->
-> I didn't like what the FDA had posted about "injury," aka an
-> adverse/allergic reaction.
->
-> Luckily that gal worked in a hospital's emergency ward and
-> received prompt attention.
->
->
->
-> http://www.fda.gov/cdrh/pdf/p980044.html
->
-> SUPARTZT Dispo -- P980044
->
-> Issued January 24, 2001
-> Part 1 - Approval Order
-> Part 2 - Summary of Safety and Effectiveness
-> Part 3 - Labeling
-> Other Consumer Information
-> These documents are in a Portable Document Format (PDF). Acrobat
Reader is
-> required to read this document.
->
==========================================================
==================
->
->
-> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?
MDRFOI__ID=1036773
->
->
-> Adverse Event Report
->
-> SEIKAGAKU CORPORATION SUPARTZ SODIUM HYALURONATE
-> Catalog Number 71567761
-> Event Date 04/11/2008
-> Event Type Injury Patient Outcome Other;
-> Event Description
->
-> Event; allergic reaction. In 2008 - the pt received her 1st dose of supartz
-> injections to her knees (bilaterally). After a few hrs, she returned to work
-> and started feeling nauseated and dizzy. After four hrs, her tongue began
to
-> swell and she had difficulty breathing. She is a clerk at the local
-> emergency hosp, so she received medical attention from a resident medical
-> physician. Her tests reflected that she had edema around her heart as
well.
-> The resident physician treated her for allergic reactions and gave her
-> benadryl and steroids. After the treatment, she was doing well. She thinks
-> because she has thyroid myalgia, her body reacted differently to the
supartz
-> therapy. According to the injecting physician, she had multiple variables
-> during the time of the reaction, and it is indeterminate if the supartz was
-> actually responsible. Thyroid myalgia - symptoms are the same as those of
-> other conditions, such as chronic fatigue syndrome, under-active thyroid,
-> lyme disease, lupus, and multiple chemical sensitivity. It is diagnosed when
-> the others cannot. The pt had a suspicion that her reaction was related to
-> the disease; however, the physician does not share her opinion. He
suspects
-> the infection was obtained through the injection site. The pt had bilateral
-> injections but only was affected in one of her knees. If the pt's disease
-> was a factor, it would have affected both knees. He stated variables such
as
-> the swelling was isolated to one knee and not both, she had cortisone
shots
-> the days before to both of her hips, she was not allergic to chicken
-> products, and the her signs and symptoms were not clinically evident upon
-> eval. Based upon these findings, he stated that it was indeterminate to the
-> actual cause of her reaction. As a precautionary measure, she was treated
-> with steroids and benadryl and is doing well. No further incidents were
-> reported.
->
->
-> Manufacturer Narrative
-> Our medical adviser suggested as follows: since this adverse event
occurred
-> a few hrs after supartz injection, and the pt had difficulty breathing after
-> four hrs, it is considered to be hypersensitive reaction to supartz
-> injection, and causal relationship between the event and supartz injection
-> cannot be denied. However, it is difficult to consider the adverse event as
-> allergic reaction to supartz itself because supartz injection was the first
-> time for the pt. The injecting physician gave supartz injection to
-> bilateral knees, but swelling developed one of her knees, so he suspects
-> infection. The pt had steroid injection to her hips the days before, and it
-> is also suspected that she had latent infection preliminarily. The pt
-> reported to have complication of thyroid myalgia. It seems that thyroid
-> myalgia can cause a hypersensitive condition to multiple chemicals.
-> Considering the pt's condition, it is presumable the allergic reaction was
-> caused by injecting procedures-inducible components of bacteria or fungi.
->
->
-> Brand NameSUPARTZ
-> Type of DeviceSODIUM HYALURONATE
-> Baseline Device 510(K) Number
-> Baseline Device PMA Number
-> Manufacturer (Section F) SEIKAGAKU CORPORATION
-> 6-1, marunouchi 1-chome,
-> chiyoda-ku
-> tokyo
-> JAPAN 100-0005
->
-> Manufacturer (Section D) SEIKAGAKU CORPORATION
-> 6-1, marunouchi 1-chome,
-> chiyoda-ku
-> tokyo
-> JAPAN 100-0005
->
-> Manufacturer (Section G) SEIKAGAKU CORPORATION
-> 6-1, marunouchi 1-chome,
-> chiyoda-ku
-> tokyo
-> JAPAN 100-0005
->
-> Manufacturer Contactphillip emmert, ms, sr specialist
-> 1450 brookd rd
-> memphis, TN 38116
-> (901) 399 -5296
->
-> Device Event Key1005853
-> MDR Report Key1036773
-> Event Key995144
-> Report Number9612392-2008-00003
-> Device Sequence Number1
-> Product CodeMOZ
-> Report SourceManufacturer
-> Source TypeHealth Professional
-> Reporter OccupationPhysician
-> Type of Report Initial
-> Report Date04/28/2008
-> 1 Device Was Involved in the Event
-> 1 Patient Was Involved in the Event
-> Date FDA Received04/28/2008
-> Is This An Adverse Event Report?Yes
-> Is This A Product Problem Report?No
-> Device OperatorHealth Professional
-> Device Catalogue Number71567761
-> Device LOT Number7C168N
-> Was Device Available For Evaluation?No
-> Is The Reporter A Health Professional?Yes
-> Was the Report Sent to FDA?No
-> Event LocationOther
-> Was The Report Sent To Manufacturer?No
-> Date Manufacturer Received04/16/2008
-> Was Device Evaluated By Manufacturer?Device Not Returned To
Manufacturer
-> Date Device Manufactured03/01/2007
-> Is The Device Single Use?Yes
-> Is the Device an Implant?Yes
-> Is this an Explanted Device?
-> Type of Device UsageInitial
->
-> Patient TREATMENT DATA
-> Date Received: 04/28/2008 Patient Sequence Number: 1
-> #TreatmentTreatment Date
-> 1,TRADE NAME (GENERIC NAME),
-> 2,ROUTE OF ADMIN,
-> 3,DAILY DOSE,
-> 4,INITIAL DATE & FINAL DATE OF ADMIN,
-> 5,MOTRIN ,
-> 6,BLOOD PRESSURE MEDICINE,
->
-> Database last updated on June 30, 2008
->
->
-> ... Tom's incompetence knows no barriers of country or newsgroup.
-> ___ Blue Wave/QWK v2.12

 | 
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