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