BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAMER INTL FOLEY TRAY 14FR

    MDR report key: 1162298 · Received September 5, 2008

    Report

    Report Number
    9612030-2008-00018
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 5, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 09/03/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A URINARY CATHETER. THE CLIENT IS REPORTING THAT THE DEVICE COULD NOT BE REMOVED, AS THE BALLOON COULD NOT BE DEFLATED; THE BALLOON WAS PRICKED WITH A NEEDLE TO DEFLATE; THIS PT IS ON ANTICOAGULANT TREATMENT; SUPERFICIAL LESIONS ON THE URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMER INTL FOLEY TRAY 14FR URINARY CATHETER KOD TYCO HEALTHCARE/KENDALL 16114 805960864

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK