MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE PFS 48MG/6ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  Death  

Event Description

Spontaneous call, patients daughter reported patient passed away on (b)(6) 2022.Cause not reported, no other information.Indication: unilateral primary osteoarthritis, left knee.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYNVISC ONE PFS 48MG/6ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 13901143
• MDR Text Key: 288030897
• Report Number: MW5108495
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 91 YR
• Patient Sex: Female