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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 0021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Nausea (1970); Pain (1994); Chills (2191); Shaking/Tremors (2515)
Event Date 02/01/2001
Event Type  No Answer Provided  
Event Description
Took 3 shots in knee 1st and 2nd were perfect; 3rd right swelling, big red areas, headache, nausea, shaking, pain, chills, in bed for weeks. Now walk with a cane. "what letter¿ "i¿m out going to allergist, and pain doctor ¿ internist. Nightmare results from the 3rd shot i requested to dr (b)(6) and then to company of synvisc then to fda. Wash increase at what could stopped the numbers of cases the reported problems. If i had been told all of this with my allergist i never could have tried. Asked dr to ¿cr¿ records in this office before i start ¿ only asked if i was allergic to eggs, answer no. ".
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10816294
MDR Text Key216115779
Report NumberMW5097745
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 Patient
Type of Report Initial
Report Date 05/27/2001
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number0021
Was Device Available for Evaluation? No Answer Provided
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

Patient Treatment Data
Date Received: 11/09/2020 Patient Sequence Number: 1
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