MAUDE Adverse Event Report: SANOFI / GENZYME SYNVISC ONE

Lot Number 7RSL021

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 11/30/2017

Event Type  Injury  

Event Description

Pt reported increased pain after injection.

• Brand Name: SYNVISC ONE
• Type of Device: SYNVISC ONE
• Manufacturer (Section D): SANOFI / GENZYME
• MDR Report Key: 7203008
• MDR Text Key: 97787729
• Report Number: MW5074661
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 01/15/2018

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
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other