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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Visual Disturbances (2140)

Event Date 08/30/2019

Event Type  Injury  

Event Description

Pt is experiencing double vision after the 2nd injection of gelsyn-3.Pt has gone to eye dr and primary care dr to make sure not a stroke or further eye problems.Wearing a patch helps.Received 3rd injection this week and did not further cause eye problems.Also lots of bruising locally after 2nd injection.Rph.

• Brand Name: GELSYN-3 INJ 16.8/2ML
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): IBSA PHARMA, INC.
• MDR Report Key: 8971011
• MDR Text Key: 157326074
• Report Number: MW5089623
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130311101
• UDI-Public: 89130311101
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2019
• Patient Sequence Number: 1
• Patient Age: 77 YR