BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIFIX ANORECTAL BALLOON HOLDER

    MDR report key: 3535776 · Received November 14, 2013

    Report

    Report Number
    2023374-2013-00001
    Event Type
    Other
    Date Received
    November 14, 2013
    Date of Event
    October 15, 2013
    Report Date
    November 14, 2013
    Manufacturer
    SANDHILL SCIENTIFIC, INC.
    Product Code
    EXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BAND HOLDER DID NOT HOLD THE BALLOON ON THE ANORECTAL PROBE WHEN THE PROBE WAS REMOVED. THE BALLOON WAS LOST WITHIN THE PATIENT'S COLON. A SIGMOIDOSCOPY WAS PERFORMED TO REMOVE THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592269 UNIFIX ANORECTAL BALLOON HOLDER UNIFIX ANORECTAL BALLOON HOLDER EXX SANDHILL SCIENTIFIC, INC. A86-4400-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention