MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE PFS 8MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  Injury  

Event Description

The doctor's office confirmed this patient is being treated with synvisc-one for his left knee and also bilateral shoulders.The dr is aware of off-label dosing of synvisc-one for the shoulders and wants to continue.

• Brand Name: SYNVISC ONE PFS 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11613201
• MDR Text Key: 244035604
• Report Number: MW5100545
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR