BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR

    MDR report key: 856796 · Received May 25, 2007

    Report

    Report Number
    2522801-2007-00005
    Event Type
    Other
    Date Received
    May 25, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 25, 2007
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION CAN BE PERFORMED ON THE "USED" THREAD THAT WAS REMOVED FROM THE PATIENT'S FACE. THE REVIEW OF THE DEVICE HISTORY RECORDS VERIFIED THAT THIS SPECIFIC LOT OF CT400 MET ALL USP AND SSC REQUIREMENTS AT TIME OF RELEASE AND THE STERILITY TESTING REQUIREMENTS WERE WITHIN SPECIFICATION. ACCORDING TO (DR.'S ASSISTANT) THE PATIENT IS RESPONDING WELL TO THE CURRENT ANTIBIOTIC REGIMEN.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN INFECTION IN THE LEFT CHEEK AREA ALMOST THREE (3) MONTHS POST-OP ELECTIVE MID-FACE CONTOURING PROCEDURE WITH THE 7" BI-DIRECTIONAL 55CM BARBED THREAD (CT400) EVEN THOUGH AN ANTIBIOTIC WAS PRESCRIBED PRIOR TO THE SURGERY WHICH WAS PERFORMED IN 2007. THE INFECTION WAS NOT AT THE INSERTION SITE. THE PATIENT WAS GIVEN PRESCRIPTIONS FOR "CIPROFLOXACIN" (750MG) AND "VALTREX" (500MG) AT ABOUT 10 WEEKS LATER AND THE THREAD WAS REMOVED FROM THE PATIENT'S CHECK AREA FIVE DAYS AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BARBED THREAD/NEEDLE GAB SURGICAL SPECIALTIES CORP. CT400 M935610

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention