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

Device Problem Off-Label Use (1494)

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

Event Date 03/13/2020

Event Type  No Answer Provided  

Event Description

Report of off label dosing of synvisc one injected intraarticular into left shoulder one time.

• Brand Name: SYNVISC ONE INJ 8MGML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 9848222
• MDR Text Key: 184272383
• Report Number: MW5093826
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 65 YR