FDA Adverse Event
Malfunction
Summary report: N
SYNVISC (3X2ML PREFILLED SYR)
MDR report key: 12384748
·
Received August 27, 2021
Report
- Report Number
- MW5103560
- Event Type
- Malfunction
- Date Received
- August 27, 2021
- Date of Event
- July 14, 2021
- Report Date
- July 14, 2021
- Manufacturer
- GENZYME CORPORATION
- Product Code
- MOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
MD OFFICE TO REPORT THAT WHEN THE MD STAFF OPENED THE MEDICATION (TODAY (B)(6) 2021), THE PLUNGER FELL OUT. THE PATIENT HAS NOT YET STARTED THE COURSE OF THERAPY, SO THERE HAS NOT YET BEEN ANY MISSED DOSES, NO OTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1277883 | SYNVISC (3X2ML PREFILLED SYR) | ACID, HYALURONIC, INTRAARTICULAR | MOZ | GENZYME CORPORATION | 9RST023C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |