FDA Adverse Event
Injury
Summary report: N
GELSYN-3 SODIUM HYALURONATE 16.8 MG / 2 ML INJECTION 2 ML
MDR report key: 21700357
·
Received March 26, 2025
Report
- Report Number
- MW5168248
- Event Type
- Injury
- Date Received
- March 26, 2025
- Report Date
- March 19, 2025
- Manufacturer
- IBSA INSTITUT BIOCHIMIQUE SA
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE USER WAS CALLING IN NEEDING ASSISTANCE WITH THIS PHYSICIAN ASSISTANT (PA), BUT THEY STATED THEY WORKED IN A REHAB FACILITY. SINCE THIS MEDICATION WAS PRESCRIBED FOR A PATIENT IN A REHAB FACILITY, THIS IS BEING REPORTED AS A POTENTIAL ADVERSE EVENT (PAE). HEALTH CARE PROFESSIONAL (HCP) DID NOT CONSENT TO FOLLOW UP, NO FURTHER INFORMATION PROVIDED OR AVAILABLE REGARDING THIS REPORT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2657651 | GELSYN-3 SODIUM HYALURONATE 16.8 MG / 2 ML INJECTION 2 ML | ACID, HYALURONIC, INTRAARTICULAR | MOZ | IBSA INSTITUT BIOCHIMIQUE SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |