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