BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 2/0 (3) 70CM HS37 (M)

    MDR report key: 7799214 · Received August 20, 2018

    Report

    Report Number
    3003639970-2018-00531
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Report Date
    July 19, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING DATE OF EVENT: UNKNOWN. PENDING FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "NEEDLE DETACHED FROM THE THREAD, THE INCIDENT HAPPENED AT SEVERAL TIMES. IN ESTHETIC SURGERY (ABDOMINOPLASTY, BREAST REDUCTION) OCCURS WHEN THE THREAD WAS TAKEN, THE INCIDENT WAS REPEATED 5 TIMES DURING 2 DIFFERENT INTERVENTIONS. NO CONSEQUENCES FOR PATIENTS. NO DELAY. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2018-00500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640265 MONOSYN UNDYED 2/0 (3) 70CM HS37 (M) SUTURES GAM B.BRAUN SURGICAL SA C0023236 117313

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR