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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG/ML (3X2ML)

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GENZYME CORPORATION SYNVISC INJ 8MG/ML (3X2ML) Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Cellulitis (1768)
Event Date 08/07/2017
Event Type  Injury  
Event Description
Hospital event. Pt contacted was admitted for cellulitis in left leg. Has f/u plans in place.
 
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Brand NameSYNVISC INJ 8MG/ML (3X2ML)
Type of DeviceSYNVISC INJ 8MG/ML (3X2ML)
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key6816509
MDR Text Key83617924
Report NumberMW5071766
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
Type of Report Initial
Report Date 08/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
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? 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

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