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

Device Problem Off-Label Use (1494)

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

Event Date 11/07/2019

Event Type  Injury  

Event Description

Prescriber is using synvisc off-label in the shoulder.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 9315948
• MDR Text Key: 166340505
• Report Number: MW5091011
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR