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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP. SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORP. SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Weakness (2145); Numbness (2415)
Event Date 03/13/2020
Event Type  Injury  
Event Description
Weakness and numbness in whole leg.
 
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Brand NameSYNVISC ONE INJ 8MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORP.
MDR Report Key9840516
MDR Text Key183942561
Report NumberMW5093785
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
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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