BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH18

    MDR report key: 2961287 · Received February 8, 2013

    Report

    Report Number
    9611710-2013-00099
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 3, 2010
    Report Date
    December 24, 2010
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THREE UNSUCCESSFUL ATTEMPTS TO GET MORE DETAILS REGARDING HOW THE CATHETER WAS FINALLY REMOVED IN ORDER TO MAKE MEDICAL DETERMINATIONS, AND IN ORDER TO ERR ON THE SIDE OF CAUTION, THIS CASE IS BEING DEEMED A MALFUNCTION AS WE HAVE NO INFO THAT ANY HARM WAS CAUSED TO A PT. IN ADDITION, IT WAS STATED THAT NO HARM WAS INCURRED. WE DETERMINED, HOWEVER, THAT A RECURRENCE OF THIS MALFUNCTION WOULD LIKELY LEAD TO A SERIOUS ADVERSE EVENT BECAUSE, IN SOME PAST CASES, PTS HAVE HAD TO UNDERGO AN INVASIVE MEDICAL PROCEDURE IN ORDER TO DEFLATE THE BALLOON AND REMOVE THE CATHETER FROM THE BLADDER. THE PRODUCT(S) NOTED IN THIS CASE IS/ARE NOT USED FOR TREATMENT OR DIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(4). "THE BALLOON DOESN'T WITHER CUSTOMER COMPLAINT (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55117 FOLEY CATHETER, 2W STD SEC CH18 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD 721810150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention