BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMBERLY CLARK

    MDR report key: 2138241 · Received June 19, 2011

    Report

    Report Number
    MW5021061
    Event Type
    Other
    Date Received
    June 19, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 19, 2011
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A MEDICAL DEVICE CALLED ONQ WAS INSERTED INTO THE AREA OF MY SURGERY FOR PAIN MANAGEMENT. THE DEVICE EITHER MALFUNCTIONED OR WAS INCORRECTLY IMPLANTED BY THE DOCTORS AT (B)(6) HOSPITAL IN (B)(6). I WAS IN GREAT PAIN FOLLOWING THE SURGERY AND TOLD TO TAKE ASPIRIN. THEY GAVE ME TYLENOL FOR THE PAIN SINCE I HAVE ADVERSE REACTIONS TO MOST PAIN MEDICATION OTHER THAN MORPHINE, USUALLY 15 MG. THE DEVICE NEVER DELIVERED MEDICATION OR IF IT DID IT DIDN'T CONTINUE TO DO SO. I STILL HAVE THE DEVICE AND IT IS FULL. AFTER THREE DAYS I WAS TOLD TO DISCONTINUE THE USE AND PULL OUT THE TUBE. WHEN THE TUBE WAS REMOVED, NOTHING CAME OUT. THE LOT NUMBER OF THE ONQ 142651. IT CONTAINS 335 ML AND WAS SUPPOSED TO DELIVER 2 ML/HR. YOU WOULD THINK THAT AFTER THREE DAYS THE CONTAINER WOULD NOT BE AS FULL AS IT IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK ONQ BY I - FLOW 2ML/HR, 335ML MEB 142651

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other