FDA Adverse Event
Malfunction
Summary report: N
SYNVISC HYLAN G-F-20
MDR report key: 10811162
·
Received November 6, 2020
Report
- Report Number
- MW5097718
- Event Type
- Malfunction
- Date Received
- November 6, 2020
- Date of Event
- February 3, 2000
- Report Date
- December 11, 2000
- Manufacturer
- GENZYME CORPORATION
- Product Code
- MOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NV, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
I WAS GIVEN SYNVISC IN MY HAND. IT WAS APPROVED FOR KNEES ONLY. I HAVE HAD SEVERE SWELLING, PAIN AND MENTAL DISTRESS SINCE. THE DOCTOR THAT GAVE ME THIS TREATMENT NEVER ONCE TOOK ANY TESTS OR X-RAYS BEFORE TREATING ME WITH THIS TREATMENT. I HAVE SINCE HAD SURGERY TO REPAIR MY HAND AND I WAS BLOWN OFF MY BIOMATRIX INC. AND THE DOCTOR THAT GAVE ME THIS TREATMENT. I WANT SATISFACTION. I AM AT THE PRESENT TIME UNABLE TO WORK AND NOW MY FINANCIAL SITUATION IS NOT GOOD, PLEASE HELP ME. SINCE THE TREATMENT I WENT TO ANOTHER DOCTOR AND HE DID THE NERVE TEST TO SHOW THAT I HAD CARPAL TUNNEL, AND I NEEDED SOME PAINFUL HARDWARE REMOVED. ALSO I HAD SCAR TISSUE ON THE RADIAL NERVE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1262993 | SYNVISC HYLAN G-F-20 | ACID, HYALURONIC, INTRAARTICULAR | MOZ | GENZYME CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |