BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER ENEMA AIR TIP

    MDR report key: 755170 · Received October 14, 2005

    Report

    Report Number
    MW1040171
    Event Type
    Malfunction
    Date Received
    October 14, 2005
    Date of Event
    September 26, 2005
    Report Date
    October 14, 2005
    Manufacturer
    EZEM INCORP
    Product Code
    FGD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SIMULATED FOR PELVIC XRT W/RECTAL BALLOON. BALLOON WAS INFLATED BUT DID NOT HOLD THROUGH CT SCAN. WASN'T NOTICED UNTIL DR WENT TO DRAW CONTOURS FOR PLAN. THEREFORE DR ORDERED NEW CT SCAN TO BE PERFORMED AGAIN WITH NEW RECTAL BALLOON DELAYING PT'S TREATMENT. PER STAFF, QUESTION IF DEFECT WAS IN BALLOON OR GLUE WHERE TIP ATTACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER ENEMA AIR TIP RECTAL BALLOON FGD EZEM INCORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR