BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKEMORE TUBE

    MDR report key: 84909 · Received April 18, 1997

    Report

    Report Number
    8010095-1997-00036
    Event Type
    Injury
    Date Received
    April 18, 1997
    Report Date
    April 18, 1997
    Manufacturer
    RUSCH MFG. UK, LTD.
    Product Code
    KDH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS STATED THAT PHYSICIAN ATTEMPTED TO USE THREE OF THE SAME ITEM. THE FIRST TWO, THE BALLOON STUCK TO THE PAPER AND THE THIRD WAS STUCK AS WELL BUT PHYSICIAN WAS ABLE TO SEPARATE THE BALLOON FROM THE PAPER AND USE THE DEVICE. IT WAS STATED THAT THIS DEVICE HAS BOTH BALLOONS MARKED GASTRIC WHILE ONE OF THESE SHOULD HAVE BEEN MARKED OSOPHAGEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKEMORE TUBE SENGSTAKEN TUBES KDH RUSCH MFG. UK, LTD. NA E342136

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention