FDA Adverse Event
Other
Summary report: N
GELSYN 3
MDR report key: 19477167
·
Received June 5, 2024
Report
- Report Number
- MW5155787
- Event Type
- Other
- Date Received
- June 5, 2024
- Report Date
- June 3, 2024
- Manufacturer
- IBSA FARMACEUTICI ITALIA SRL
- Product Code
- MOZ
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE OV STATED THAT SHE WAS HAVING DISCOMFORT AND MORE PAIN SINCE DOING TWO SERIES OF GELSYN. THE PATIENT STATED THAT SHE HAS DONE MUCH BETTER IN THE PAST WITH NONPREFERRED DRUG HYALGAN AE-46643 REPORTED BY HEALTH CARE PERSONNEL AND CONSENTED TO FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2320092 | GELSYN 3 | ACID, HYALURONIC, INTRAARTICULAR | MOZ | IBSA FARMACEUTICI ITALIA SRL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |