BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIONE GT EXTENSION

    MDR report key: 8855720 · Received July 31, 2019

    Report

    Report Number
    MW5088657
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Report Date
    July 29, 2019
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY (AMT), INC.
    Product Code
    PIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENTS G TUBE EXTENSION CRACKED AT MED PORT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638759 MINIONE GT EXTENSION GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF APPLIED MEDICAL TECHNOLOGY (AMT), INC. 190626-408

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR