BEUDAMED
    FDA Adverse Event Summary report: N

    MIC GASTROSTOMY TUBE, 14 FR

    MDR report key: 17920 · Received November 22, 1994

    Report

    Report Number
    MW1004114
    Date Received
    November 22, 1994
    Date of Event
    November 12, 1994
    Report Date
    November 15, 1994
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNT
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER CALLED REGARDING BURST BALLOON ON TUBE, REQUESTING REPLACEMENT. PT'S MOTHER HAS BEEN USING TUBES FOR SEVERAL YEARS SO RPTR WAS NOT BELIEVE THIS IS MISUSE BY CONSUMER. THIS IS 4TH BALLOON ON THIS PT TO HAVE BURST. MFR HAS BEEN NOTIFIED PREVIOUSLY. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC GASTROSTOMY TUBE, 14 FR KNT MEDICAL INNOVATIONS CORP. 4020402

    Patients

    Seq Age Sex Outcome Treatment
    1 *