MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG / ML (3X2 ML); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Off-Label Use (1494)

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

Event Date 09/18/2019

Event Type  Injury  

Event Description

(b)(6), pt coord at dr (b)(6) office verified they are aware of off-label usage for synvisc in osteoarthritis of shoulder.They confirmed route to be injected intra-articularly into left shoulder as prescribed.

• Brand Name: SYNVISC INJ 8MG / ML (3X2 ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 9118106
• MDR Text Key: 160176280
• Report Number: MW5090021
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• 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: 82 YR