FDA Adverse Event
Injury
Summary report: N
GELSYN-3 16.8 MG/2ML SYR (2=1)
MDR report key: 14488400
·
Received May 23, 2022
Report
- Report Number
- MW5109858
- Event Type
- Injury
- Date Received
- May 23, 2022
- Report Date
- May 20, 2022
- Manufacturer
- IBSA FARMACEUTICI ITALIA SRL
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT REPORTED HAVING MACULAR DEGENERATION. INJECT 1 SYRINGE INTRA-ARTICULARLY IN THE RIGHT KNEE ONCE PER WEEK FOR 3 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150534 | GELSYN-3 16.8 MG/2ML SYR (2=1) | ACID, HYALURONIC, INTRAARTICULAR | MOZ | IBSA FARMACEUTICI ITALIA SRL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |