BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH BELLY BAG 1000ML

    MDR report key: 1303825 · Received January 6, 2009

    Report

    Report Number
    3004365956-2009-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2009
    Report Date
    October 29, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS REQUESTED, BUT NOT RECEIVED OR EVALUATED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED, BY THE END USER, TO A TELEFLEX MEDICAL REP. ON (B) (6) 2008. THE END USER REPORTS WAKING UP WITH AN OVER-FILLED BLADDER. THE END USER STATES THAT THE BELLY BAG MALFUNCTIONED AND CAUSED HEAVY BLADDER SPASMS. NO INTERVENTION OR PERMANENT DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH BELLY BAG 1000ML URINARY COLLECTION BAG KNX TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1