MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3X2ML); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  Injury  

Event Description

Md is aware that dosing synvisc every 3 months is outside fda guidelines and would like to continue with the rx.The pt is not a candidate for knee surgery.

• Brand Name: SYNVISC INJ 8MG/ML (3X2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 8274081
• MDR Text Key: 134185701
• Report Number: MW5083339
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/17/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR