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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2021

Event Type  Death  

Event Description

Pt deceased.

• Brand Name: SYNVISC PFS 8MG/ML (3X2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 12216858
• MDR Text Key: 263372108
• Report Number: MW5102720
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• 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 Outcome(s): Death
• Patient Age: 92 YR