BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOLEY CATHETER, 2W HARD VALVE SIL ELASTOMER CO

    MDR report key: 2922257 · Received January 16, 2013

    Report

    Report Number
    9611710-2013-00009
    Event Type
    Other
    Date Received
    January 16, 2013
    Date of Event
    October 30, 2012
    Report Date
    January 16, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). THE ADVERSE EVENT IS DEEMED SERIOUS AS IT REQUIRED MEDICAL / SURGICAL INTERVENTION TO REMOVE THE CATHETER WHOSE BALLOON HAD FAILED TO DEFLATE. IF FORCIBLY REMOVED WITH THE BALLOON FULLY INFLATED, THIS COULD HAVE RESULTED IN SERIOUS HARM TO THE PT. THE SURGEON IN THE CASE HAD TO USE A LOCAL ANESTHESIA ON THE URETHRA TO FACILITATE THE REMOVAL OF THE FULLY INFLATED BALLOON.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: CATHETER WAS PLACED IN GYNECOLOGICAL PROCEDURE. WHEN THE CATHETER SHOULD BE REMOVED BY THE SURGEON, HE COULD NOT EMPTY THE BALLOON. THE CATHETER WAS ALSO CUT, BUT WITHOUT ANY RESULTS. THE SURGEON HAD TO BLOCK THE URETER (URETHRA) TO BE ABLE TO REMOVE THE CATHETER WHICH HAD FULL BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24050 FOLEY CATHETER, 2W HARD VALVE SIL ELASTOMER CO UROLOGICAL CATHETER ADN ACCESSORIES KOD UNOMEDICAL SDN BHD MM53160805 499065R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention