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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Pt is deceased.

• Brand Name: SYNVISC ONE PFS 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 16529124
• MDR Text Key: 311156648
• Report Number: MW5115647
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White