BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECKSTAT STAPLE REMOVER

    MDR report key: 3020996 · Received March 20, 2013

    Report

    Report Number
    3003898360-2013-00116
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE NOT RETURNED TO MFR IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: THE STAPLES ARE NOT BEING REMOVED IN A "M" SHAPE BUT RATHER THEY ARE COMING OUT "SPLAYED", CAUSING PAIN. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115717 WECKSTAT STAPLE REMOVER SKIN STAPLE REMOVER MDM TELEFLEX MEDICAL 01D1200334

    Patients

    Seq Age Sex Outcome Treatment
    1