BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF CATH FEMALE CH14

    MDR report key: 2173348 · Received July 23, 2011

    Report

    Report Number
    3005945907-2011-00015
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 20, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZD
    PMA / PMN Number
    K100878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. A REVIEW OF THE PRODUCT DOCUMENTATION REVEALS NO RELATED DEVIATIONS, AND NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED TO DATE FOR THIS LOT NUMBER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, AN END USER REPORTED THAT SHE WENT THROUGH A BOX OF 30 CATHETERS AND WHEN SHE GOT TO THE LAST ONE, SHE NOTICED A DEAD BUG INSIDE THE WRAPPING OF THE CATHETER. SHE HAD NOT NOTICED ANYTHING IN THE PREVIOUS 29 CATHETERS BUT SHE SAID SHE HAS BEEN HAVING A LOT OF UTIS LATELY AND WONDERED IF IT WAS RELATED TO THE CATHETERS. END USER HAS 7-8 MORE BOXES WITH THE SAME LOT NUMBER. SHE OPENED ONE OF THEM AND THERE WERE BLACK CRUMB-LIKE THINGS ON THE OUTSIDE OF THE CATHETER THAT RUBBED RIGHT OFF BUT WAS CONCERNED ABOUT THE STERILITY OF THE PRODUCT. SHE HAS BEEN USING THE PRODUCTS FOR ABOUT 20 OR SO YEARS AND UNTIL RECENTLY HAS NOT HAD ANY PROBLEMS. A FEW MONTHS AGO, SHE ALSO HAD A CATHETER THAT WAS CUT AT THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF CATH FEMALE CH14 CATHETER, UROLOGICAL EZD COLOPLAST A/S 5046301400 2666912

    Patients

    Seq Age Sex Outcome Treatment
    1