BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBBE

    MDR report key: 378259 · Received February 8, 2002

    Report

    Report Number
    MW4003194
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Report Date
    February 8, 2002
    Manufacturer
    TILLER MIND BODY, INC
    Product Code
    GBT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER IS CONCERNED ABOUT THE QUALITY CONTROL OF THE COMPOSITION OF THE PLASTIC USED TO MAKE THE TUBES. THEY STATE THAT AT 102 DEGREES, THE TUBES IN SOME LOTS BECOME SO SOFT THAT THE SPHINCTER MUSCLE IS ABLE TO COLLAPSE THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBBE RECTAL TUBE GBT TILLER MIND BODY, INC NA 123504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA