BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH14

    MDR report key: 3002094 · Received February 12, 2013

    Report

    Report Number
    9611710-2013-00101
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 10, 2011
    Report Date
    January 10, 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)(6). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM (B)(4)). THIS CASE IS DEEMED A MALFUNCTION, WHICH, IF IT RECURRED COULD LEAD TO A SERIOUS ADVERSE EVENT BECAUSE THERE HAVE BEEN OCCASIONS WHERE THE BALLOON REQUIRED DEFLATING BY THE TRANSVAGINAL OR SUPRAPUBIC ROUTE, WHICH PUTS THE PATIENT AT SUBSTANTIAL RISK FOR INFECTION OR A MORE SERIOUS OUTCOME FROM THIS PROCEDURE. THE PRODUCT(S) NOTED IN THIS CASE IS/ARE NOT USED FOR TREATMENT OR DIAGNOSIS. REPORTED TO THE FDA ON (B)(6) 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)(6). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM (B)(4)). THE BALLOON DOES NOT DEFLATE FOR THE CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62239 FOLEY CATHETER, 2W STD SEC CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD AA14141002 401141R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening