MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problems Unexpected Therapeutic Results (1631); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 09/27/2021

Event Type  Injury  

Event Description

After my third injection of synvisc - administered (b)(6) 2021 by my orthopedic physician at ui health, i gradually began experiencing painful side effects to this drug.Since the first dosage, i had supplemented this medication with sulindac, 200 mg.Osteoarthritic pain relief/management.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 12583179
• MDR Text Key: 275173076
• Report Number: MW5104398
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2021

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 69