BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPRI BLADDER CONTROL PADS

    MDR report key: 6185090 · Received December 13, 2016

    Report

    Report Number
    MW5066738
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    December 10, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    KME
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HERE'S WHAT I SENT TO (B)(6) ON (B)(6) MESSAGE ABOUT THE SITUATION: I HAVE ANOTHER ISSUE WITH ANOTHER BLADDER CONTROL PAD. I FOUND THIS ONE ON HERE WHEN I TOOK THIS OUT OF THE WRAPPER. IT'S NOT EVEN FAIR TO ME TO HAVE THESE KINDS OF ISSUES WITH THESE PRODUCTS AGAIN. IT LOOKS LIKE SOMEONE USED IT (A TISSUE OR SOMETHING IT'S GROSS AND DISTURBING). THEY REPLIED BACK ABOUT MY NUMBER AND ABOUT SOMEONE CONTACTING ME WHICH NO ONE HAS. THE FIRST MESSAGE ABOUT IT WENT OUT ON SUNDAY (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820601 CAPRI BLADDER CONTROL PADS CAPRI BLADDER CONTROL PADS KME MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR