BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMT MINI BUTTON, 5-1820, 18 FR 2.0 CM

    MDR report key: 751403 · Received July 21, 2006

    Report

    Report Number
    MW1039816
    Event Type
    Injury
    Date Received
    July 21, 2006
    Date of Event
    July 12, 2006
    Report Date
    July 13, 2006
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT'S CAREGIVER (MOTHER) INSERTED AMT MINI BUTTON AS USUAL. SHE FILLED THE BALLOON WITH 10 ML OF DISTILLED WATER PER PROTOCOL. FIVE MINUTES LATER, PATIENT DESCRIBED FEELING WATER IN HER THROAT AND BEGAN TO CRY. CAREGIVER CHECKED DEVICE BY PULLING BACK WITH A SYRINGE. SHE FOUND THAT BALLOON HAD RUPTURED, LEAKING FLUID. SHE REMOVED THE MINI BUTTON AND REPLACED IT WITH THE OLD ONE. CAREGIVER CALLED THIS PHARMACIST TO REPORT IT. SHE DID. THEY DID NOT TAKE DOWN ANY INFORMATION (IE: LOT NUMBER) BUT DID OFFER TO SEND HER A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMT MINI BUTTON, 5-1820, 18 FR 2.0 CM PEG TUBE KNT APPLIED MEDICAL TECHNOLOGIES 5-1820 05040417

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention