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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 10/05/2020

Event Type  Injury  

Event Description

Dr added gabapentin 100 mg 2/day and 300 mg at night for nerve pain.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME
• MDR Report Key: 10770166
• MDR Text Key: 214369659
• Report Number: MW5097575
• 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: Unknown
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information

Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data

Date Received: 10/30/2020 Patient Sequence Number: 1