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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8 MG/ML (3X2 ML) ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC INJ 8 MG/ML (3X2 ML) ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2020
Event Type  Injury  
Event Description
Doctor¿s office confirmed that the doctor is aware of the off-label use for synvisc injecting weekly for 5 weeks and would like to proceed with the prescription as written.
 
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Brand NameSYNVISC INJ 8 MG/ML (3X2 ML)
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key9686792
MDR Text Key178570779
Report NumberMW5092874
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
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
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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