BEUDAMED
    FDA Adverse Event Death Summary report: N

    LATEX FOLEY

    MDR report key: 4764552 · Received May 8, 2015

    Report

    Report Number
    1018233-2015-00147
    Event Type
    Death
    Date Received
    May 8, 2015
    Report Date
    April 16, 2015
    Manufacturer
    BARD SDN. BHD.
    Product Code
    KOD
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE LABELING COULD NOT BE REVIEWED DUE TO NO PRODUCT CATALOG NUMBER WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED BY THE FACILITY THAT THE NURSE INSERTED A LATEX FOLEY INTO A PT WITH A KNOWN LATEX ALLERGY. THE PT WAS PUT ON VENTILATOR SUPPORT AFTER AN UNK LENGTH OF TIME AFTER THE FOLEY WAS PLACED. THE FACILITY REPORTED THE PT LATER DIED. THROUGH CLINICAL FOLLOW UP THE FACILITY LATER RECANTED THEIR STATEMENT BY INFORMING BARD THAT THE PT SUFFERED NO IMPACT AS A RESULT OF THE FOLEY CATHETER BEING PLACED. THE HOSPITAL REPORTS THE PT SUFFERED NO REACTION TO THE LATEX FOLEY. THE HOSPITAL ALSO REPORTS THE PT PASSED AWAY FROM RESPIRATORY FAILURE, NOT FROM THE LATEX FOLEY BEING PLACED. THE HOSPITAL REFUSES TO PROVIDE ADDITIONAL INFO SURROUNDING THIS EVEN. WHILE THE HOSPITAL FEELS THE PT SUFFERED NO IMPACT AS A RESULT OF THE USE ERROR INVOLVING ONE OUR PRODUCTS; BARD IS REPORTING THE ADVERSE EVENT INVOLVED WITH ONE OF OUR FOLEY CATHETERS EVEN IN THE ABSENCE OF INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302768 LATEX FOLEY KOD BARD SDN. BHD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death VENTILATOR SUPPORT