BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH14

    MDR report key: 2935091 · Received January 28, 2013

    Report

    Report Number
    9611710-2013-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    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 (B)(6). THIS IS RELATED TO ((B)(4)). BASED ON AVAILABLE INFO, 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. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR "PRIVATE LABEL" PRODUCT ((B)(4)). THIS COMPLAINT WAS RECEIVED BY (B)(6) ON (B)(6) 2012 FROM (B)(6) FOR PRODUCT 2 WAY STANDARD SEC FOLEY CATHETER SIZE 14X10. CUSTOMER COMPLAINING:" NON DEFLATION - AT THE PRIOR TEST BEFORE USE, IT WAS POSSIBLE TO INFLATE AND DEFLATE THE BALLOON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37792 FOLEY CATHETER, 2W STD SEC CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD E210-14TN 403609R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention