FDA Adverse Event
Injury
Summary report: N
GELSYN-3
MDR report key: 15103961
·
Received July 25, 2022
Report
- Report Number
- MW5111102
- Event Type
- Injury
- Date Received
- July 25, 2022
- Report Date
- July 21, 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
THE PT REPORTED ANKLE SWELLING MD TO INJECT 1 SYRINGE INTRA-ARTICULARLY INTO THE AFFECTED KNEE(S) EACH WEEK FOR 3 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1432954 | GELSYN-3 | ACID, HYALURONIC, INTRAARTICULAR | MOZ | IBSA FARMACEUTICI ITALIA SRL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | CRESTOR TAB 5 MG| DEXILANT CAP 60 MG DR| DOXEPIN HCL CAP 50 MG| SYNTHROID TAB 137 MCG |