BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKER TUBE

    MDR report key: 12898 · Received April 22, 1994

    Report

    Report Number
    MW1001691
    Event Type
    Malfunction
    Date Received
    April 22, 1994
    Date of Event
    April 3, 1994
    Report Date
    April 7, 1994
    Manufacturer
    BISSELL MEDICAL PRODUCTS, INC.
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBE INSERTED IN OR AND BALLOON INFLATED WITH 5 CC. ADD'L FIVE CC INSERTED AND BALLOON BURST (15 CC BALLOON). NEW TUBE INSERTED AND SAME SCENARIO OCCURRED. SURGEON ADVANCED IT AND INFLATED DISTAL TUBE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAKER TUBE TWIN CUFF SELF-SUMPING TUBE FOR PLICATION OF SMALL BOWEL FEG BISSELL MEDICAL PRODUCTS, INC. 013067, 9010, 818311

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other