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

Lot Number	7RSI021
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414); Test Result (2695)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): SANOFI GENZYME
• MDR Report Key: 7142071
• Report Number: MW5074174
• Device Sequence Number: 1131811
• Product Code: MOZ
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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
• Operator of Device: No Information
• Device Expiration Date: 05/31/2017
• Device Lot Number: 7RSI021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other