BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 4/0(1,5)70CM DS16MDDP

    MDR report key: 9629834 · Received January 24, 2020

    Report

    Report Number
    3003639970-2020-00015
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 24, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K122734. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DETACHES FROM THE THREAD. THE REPORTER INDICATED THAT DURING AN ABDOMINOPLASTY, SURGICAL PROCEDURE THE THREAD DETACHES FROM THE NEEDLE DURING THE INTERVENTION AND ANOTHER SUTURE IS REQUIRED. THE SURGICAL TIME WAS INCREASED BUT NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89406 NOVOSYN QUICK UNDY 4/0(1,5)70CM DS16MDDP SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C3046213 119103

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR