BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE REMOVER

    MDR report key: 2934550 · Received January 25, 2013

    Report

    Report Number
    2934550
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    September 14, 2012
    Report Date
    January 25, 2013
    Manufacturer
    MEDLINE
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKIN STAPLES IN SCALP UNABLE TO BE REMOVED WITH STAPLE REMOVER IN USUAL MANNER. THIS REQUIRED THE PROVIDER TO CUT THE STAPLE WITH WIRE CUTTERS AND REMOVE THE PIECES; NO HARM AND PATIENT WAS DISCHARGED. STAPLES WERE IN PLACE FOR 7 DAYS. THIS FACILITY IS SEEING A RECURRING PROBLEM WITH THESE STAPLES AND STAPLE REMOVER: AS A RESULT, THE FACILITY HAS REMOVED THESE PRODUCTS AND REPLACED THEM WITH PRODUCTS MADE BY A DIFFERENT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36154 STAPLE REMOVER SKIN STAPLE REMOVER GDT MEDLINE * *
    36155 STAPLES STAPLES GDT MEDLINE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR NO OTHER THERAPIES