FDA Adverse Event
Injury
Summary report: N
GELSYN-3
MDR report key: 8658647
·
Received May 30, 2019
Report
- Report Number
- MW5087047
- Event Type
- Injury
- Date Received
- May 30, 2019
- Date of Event
- May 21, 2019
- Report Date
- May 22, 2019
- Manufacturer
- IBSA FARMACEUTICI ITALIA SRL
- Product Code
- MOZ
- UDI-DI
- 89130311101
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT REPORTS SOME PAIN IN KNEE DAY AFTER INJECTION OF GELSYN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450158 | GELSYN-3 | ACID, HYALURONIC, INTRAARTICULAR | MOZ | IBSA FARMACEUTICI ITALIA SRL | 89130311101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |