BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMESILK

    MDR report key: 6083488 · Received November 7, 2016

    Report

    Report Number
    3003063934-2015-00001
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    August 29, 2015
    Report Date
    December 18, 2015
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    GAP
    PMA / PMN Number
    K023029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NEEDLE WAS SEPARATED FROM THREAD DURING OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735414 DEMESILK SILK SUTURE GAP DEMETECH CORPORATION SK260045F4P YY219-13

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR