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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number J808
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Nausea (1970); Tachycardia (2095); Weakness (2145)
Event Date 11/24/1998
Event Type  Injury  
Event Description
Pt received synvisc 2 ml in right knee intraarticular as 1st injection for r. A. Infection, became weak and shaky, muscle aching and nausea, also felt rapid heart beat lasted approx. 30 hours then subsided. "no rash and local knee. ".
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10836754
MDR Text Key241258907
Report NumberMW5097840
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 12/01/1998
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2000
Device Lot NumberJ808
Was Device Available for Evaluation? No Answer Provided
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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