MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL/IBSA PHARMA INC. GELSYN - 3 INJ 16.8/2 ML ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/11/2019

Event Type  Injury  

Event Description

Per (b)(6) using gelsyn 3 for both knee and shoulder is common practice for their office.

• Brand Name: GELSYN - 3 INJ 16.8/2 ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL/IBSA PHARMA INC.
• MDR Report Key: 9202999
• MDR Text Key: 162886056
• Report Number: MW5090444
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130311101
• UDI-Public: 89130311101
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage