BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX

    MDR report key: 5084784 · Received September 14, 2015

    Report

    Report Number
    MW5056215
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 14, 2015
    Manufacturer
    BARD
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT'S FOLEY CATHETER WAS REMOVED, BALLOON ROLLED ON ITSELF CAUSING A RING AND RESISTANCE WHEN FOLEY REMOVED. PT COMPLAINED OF SEVERE PAIN AND REPORTED BLEEDING AFTER FOLEY REMOVAL. PATIENT ADMITTED FOR SYNCOPAL EPISODES. FOLEY HAD BEEN PLACED AT TIME OF ADMISSION IN THE ED AND HAD BEEN IN PLACE FOR LESS THAN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605561 BARDEX ALL-SILICONE FOLEY CATHETER EZL BARD 897516 NGZF0154

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other