BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFIX RC - 5 PACK

    MDR report key: 200229 · Received December 1, 1998

    Report

    Report Number
    1223420-1998-00005
    Event Type
    Malfunction
    Date Received
    December 1, 1998
    Date of Event
    September 18, 1998
    Report Date
    November 30, 1998
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFECTION AT SURGICAL SITE POST-OPERATIVELY. HOSP BELIEVES IT IS A RESULT OF POOR STERILIZATION OF THE INSERTION GUN. 10/3/98 - SURGICAL INTERVENTION OF POST-OPERATIVE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFIX RC - 5 PACK Implant SUTURE ANCHOR MBI LI MEDICAL TECHNOLOGIES, INC. * 240-97

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention