BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM HR26

    MDR report key: 9693470 · Received February 11, 2020

    Report

    Report Number
    3003639970-2020-00063
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Report Date
    February 11, 2020
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: K990089. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SILKAM BLACK. THE CUSTOMER REPORTED THAT THERE WAS AN EMERGENCY REOPERATION OF A PATIENT DUE TO WOUND DEHISCENCE 4 DAYS AFTER SURGERY. ALL THE STITCHES WERE COMPLETELY OPEN. IT WAS INTRAOPERATIVE, GENERAL SURGERY SERVICE, IN LIVER TRANSPLANT SURGERY. SUTURE TECHNIQUE EMPLOYED: INTERRUPTED (SUTURE OF LOSING STITCHES TO ENSURE ANASTOMOSIS). THERE ARE NO SAMPLES AVAILABLE. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE, BUT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156238 SILKAM BLACK 3/0 (2) 75CM HR26 OTHER SUTURE GAP B. BRAUN SURGICAL SA C0760412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention