BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERPATCH

    MDR report key: 16763540 · Received April 17, 2023

    Report

    Report Number
    MW5116754
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 13, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE OVERPATCH SUPPLIED BY DEXCOM IS A PIECE OF JUNK, IT IS IMPOSSIBLE FOR ONE PERSON TO PUT IT ON. IT IS SO FLIMSY IT FOLDS UP ON ITSELF, YOU CANNOT PEEL IT APART BECAUSE IT STRETCHES OUT OF SHAPE. THEY DO NOT EVEN HAVE A WAY TO GET EXTRA OVERPATCH. EVERY TIME I COMPLAIN ABOUT IT TO DEXCOM, THE ANSWER IS WE SUPPLY AN OVERPATCH WITH EACH SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597963 OVERPATCH TAPE AND BANDAGE, ADHESIVE KGX DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male DEXCOM G7