BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMECAPRONE

    MDR report key: 6083502 · Received November 7, 2016

    Report

    Report Number
    3003063934-2015-00002
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 5, 2015
    Report Date
    December 18, 2015
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    GAM
    PMA / PMN Number
    K130083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SUTURE BROKE AT THE KNOT WHEN TYING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732354 DEMECAPRONE POLIGLECAPRONE 25 ABSORBABLE SURGICAL SUTURE GAM DEMETECH CORPORATION MO1173019F13M U260-14

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR