BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH14

    MDR report key: 2932438 · Received January 24, 2013

    Report

    Report Number
    9611710-2013-00018
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    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 COMPLAINTS FROM OUR FACILITY IN MALAYSIA. THIS IS RELATED TO (FDA AUDIT-OBSERVATION #7 FROM FEI (B)(4)). BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON FAILS TO DEFLATE.

    Description of Event or Problem · 1

    NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE. THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS RECEIVED BY (B)(6) ON 15TH DEC 2011 FROM TORAY MEDICAL CO LTD FOR PRODUCT 2 WAY STANDARD SEC FOLEY CATHETER SIZE 14X10. CUSTOMER COMPLAINING: "IMPOSSIBLE TO DEFLATE THE BALLOON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35265 FOLEY CATHETER, 2W STD SEC CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD E210-14TN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention