MAUDE Adverse Event Report: SANOFI GENZYME SYNVISC-ONE 48 MG/6 ML INTRA-ARTICULAR SYRINGE; ACID, HYALURONIC INTRAARTICULAR

Lot Number 7RSI021

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Reaction (2414); Test Result (2695)

Event Date 11/13/2017

Event Type  Injury  

Event Description

Given recalled synvisc one injection 7rsl021 adverse reaction noted with continued pain after injection.Has had the left knee drained twice and sent for culture.Gram stain so far has been negative with elevated wbc's.Strength: 48mg/6ml mg milligram(s).Diagnosis or reason for use (indication): chronic left knee pain, chondromalacia, osteoarthritis.

• Brand Name: SYNVISC-ONE 48 MG/6 ML INTRA-ARTICULAR SYRINGE
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): SANOFI GENZYME
• MDR Report Key: 7142071
• MDR Text Key: 95756589
• Report Number: MW5074174
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2017
• Device Lot Number: 7RSI021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other