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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858); Inflammation (1932); Chills (2191); Swelling/ Edema (4577)
Event Date 02/06/2003
Event Type  Injury  
Event Description
Pierre received shot 2 or 3 of synvisc in his knee. In less than 24 hours his leg was swollen and inflamed and he had a high fever and chills. The infection was an invasive type a strep that had been introduced by the shot. He required 3 surgeries on his knee and was hospitalized 2 1/2 weeks, four days of which were in icu. He was very close to death for four days.
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10816348
MDR Text Key216103622
Report NumberMW5097748
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 Unknown
Type of Report Initial
Report Date 02/27/2003
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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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