BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 395636 · Received May 21, 2002

    Report

    Report Number
    2246315-2002-00013
    Event Type
    Injury
    Date Received
    May 21, 2002
    Date of Event
    March 1, 2002
    Report Date
    May 20, 2002
    Manufacturer
    GENZYME BIOSURGERY/ALEX KUTA-GENZYME BIOSURGERY
    Product Code
    MDZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEPTIC ARTHRITIS. REPORT RECEIVED FROM A PHYSICIAN REGARDING A PT. THE PT RECEIVED SYNVISC INJECTION TO THE KNEE IN 2002 (3 DAYS AND 4 DAYS LATER) AND SUBSEQUENTLY DEVELOPED SEPTIC ARTHRITIS IN THE RIGHT KNEE. TWO DAYS LATER, THE PT WAS HOSPITALIZED AND RECEIVED SURGICAL DEBRIDEMENT OF RIGHT KNEE. THE PHYSICIAN ALSO REPORTED THAT THERE WAS AN ASPIRATION OF PUS DURING THE DEBRIDEMENT. THE PT RECEIVED I.V. VANCOMYCIN FOR 6 WEEKS. THE PT WAS DISCHARGED FROM THE HOSPITAL (DATE UNK) AND IS CONSIDERED COMPLETELY RECOVERED. CORRECTIVE TREATMENT: SURGICAL, DEBRIDEMENT, 6 WEEKS OF I.V. VANCOMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MDZ GENZYME BIOSURGERY/ALEX KUTA-GENZYME BIOSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention