BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMBERLY CLARKE

    MDR report key: 2941327 · Received January 25, 2013

    Report

    Report Number
    MW5028796
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 25, 2013
    Manufacturer
    KIMBERLY CLARKE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S MICKY 12FR X 1CM BUTTON HAD BEEN COMPLETELY PULLED OUT FROM HIS STOMA. WHEN OBSERVING THE BUTTON, IT WOULD NOT RE-INFLATE. APPEARED TO HAVE A HOLE OR TEAR SOMEWHERE. THIS TUBE WAS PLACED ON (B)(6), AND HAS NOT BEEN REPLACED SINCE SURGERY. IT ONLY BEING LESS THAN A MONTH OLD, THEREFORE, IT WARRANTED SOME KIND OF REPORT. NATURE OF INJURY NO SIGNIFICANT INJURY, JUST SOME PAIN WHEN REPLACING THE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36349 KIMBERLY CLARKE MICKY BUTTON KNT KIMBERLY CLARKE AA1101F01

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention