BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH16

    MDR report key: 3002040 · Received February 12, 2013

    Report

    Report Number
    9611710-2013-00103
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). THE EVENT IS DEEMED SERIOUS AS IT REQUIRED MEDICAL INTERVENTION AND LIGHT ANESTHESIA IN ORDER TO PREVENT SERIOUS BODILY HARM AND PERMANENT IMPAIRMENT. FROM A PRELIMINARY CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THIS EVENT IS DEEMED RELATED BECAUSE THE BALLOON WOULD NOT DEFLATE FOR REMOVAL EITHER BY ATTEMPTS TO WITHDRAW THE WATER OR BY CUTTING THE CATHETER CLEAN THROUGH. REPORTED TO THE FDA ON FEBRUARY 12, 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(4). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). THE BALLOON DOES NOT DEFLATE AFTER 5 / 6 DAYS OF INSERTION AND MAKES IT IMPOSSIBLE TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62237 FOLEY CATHETER, 2W STD SEC CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD AA15161002 401579R002

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R