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

Patient Problems Calcium Deposits/Calcification (1758); Fall (1848)

Event Type  Injury  

Event Description

The pt's wife reports the pt having kidney stones in november that required a stent in the kidney.He is receiving a nuclear stress test and kidney stone ablation.She also reports he had a fall at the last doctor's visit and did not have any injuries resulting from the fall.

• Brand Name: SYNVISC ONE PFS 8MG
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 18563793
• MDR Text Key: 333565334
• Report Number: MW5150632
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/19/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male