MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE 48MG/6ML SYR (6=1); ACID, HYALURONIC, INTRAARTICULAR

Lot Number DRSL026B

Patient Problem Insufficient Information (4580)

Event Date 02/21/2024

Event Type  Death  

Event Description

Event: pt passed away.Freq: inject 1 syringe intra-articularly into bilateral knees at md office.

• Brand Name: SYNVISC ONE 48MG/6ML SYR (6=1)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 18815768
• MDR Text Key: 336647540
• Report Number: MW5152203
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: DRSL026B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Female