BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3-0 MONOCRYL PS-2

    MDR report key: 2030574 · Received March 21, 2011

    Report

    Report Number
    MW5019912
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ETHICON
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE CLOSING OF INCISION DURING SURGERY, THE SUTURE NEEDLE BROKE AND THE TIP OF NEEDLE FELL IN THE WOUND. A LARGER INCISION WAS REQUIRED TO FIND AND RETRIEVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-0 MONOCRYL PS-2 SUTURE GAM ETHICON DAM444

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability