BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W SOFT VALVE STD 5/10CC CH16

    MDR report key: 2980439 · Received February 22, 2013

    Report

    Report Number
    9611710-2013-00158
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    November 28, 2011
    Report Date
    December 5, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS DEEMED SERIOUS AS IT REQUIRED MEDICAL / SURGICAL INTERVENTION PREVENT PERMANENT ALTERATION/DAMAGE TO BODILY FUNCTION. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THIS EVENT IS DEEMED RELATED BECAUSE THE BALLOON COULD NOT BE DEFLATED IN ORDER TO SAFELY REMOVE IT FROM THE BLADDER AND A PHYSICIAN HAD TO RUPTURE THE BALLOON USING A STYLET. REPORTED TO FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO ((B)(4)). COMPLAINT RECEIVED AS FOLLOWS: "NO HARM OR INJURY TO PT. NON-DEFLATION WAS NOTED IN USE. SHORTENING THE CATHETER SHAFT COULD NOT REMOVE THE FOLEY. THE VICTIM WAS SENT TO THE OPERATING ROOM AND MEDICAL STAFF USED THE STYLET TO HAVE THE BALLOON RUPTURED UNDER THE CYSTOSCOPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77605 FOLEY CATHETER, 2W SOFT VALVE STD 5/10CC CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD MM51111610 4038223R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention