BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SLC

    MDR report key: 2922146 · Received January 16, 2013

    Report

    Report Number
    9611710-2013-00006
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    August 15, 2012
    Report Date
    January 16, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K944007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON PRIVATE LABEL COMPLAINTS FROM OUR FACILITY IN (B)(4). BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE IN SOME CASES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON HAS FAILED TO DEFLATE. (B)(4).

    Description of Event or Problem · 1

    BALLOON WILL NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23491 FOLEY CATHETER, 2W STD SLC UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD HY210-16JN 539894R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention