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U.S. Department of Health and Human Services

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

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SANOFI GENZYME SYNVISC-ONE 48 MG/6 ML INTRA-ARTICULAR SYRINGE ACID, HYALURONIC INTRAARTICULAR Back to Search Results
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.

 
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Brand NameSYNVISC-ONE 48 MG/6 ML INTRA-ARTICULAR SYRINGE
Type of DeviceACID, HYALURONIC INTRAARTICULAR
Manufacturer (Section D)
SANOFI GENZYME
MDR Report Key7142071
MDR Text Key95756589
Report NumberMW5074174
Device Sequence Number1
Product Code MOZ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date05/31/2017
Device LOT Number7RSI021
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/21/2017 Patient Sequence Number: 1
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