BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREND DYNAWRAP

    MDR report key: 18921664 · Received March 18, 2024

    Report

    Report Number
    MW5152912
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 15, 2024
    Manufacturer
    TREND MEDICAL, LLC
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ORDERED TREND DYNAWRAP IN JANUARY. I THINK IT IS SAFETY AIR PUMP AS THEIR WEBSITE SAYS COMPLETE CERTIFICATES FDA 510K. THE PUMP'S BIG PRESSURE MADE THE SHOULDER WRAP EXPLODED FIRST AND THEN THE PUMP EXPLODED. AIR PUMP DEBRIS HIT MY FACE AND BLOOD. I FIND TREND MEDICAL LLC NO FDA 510K. DYNAWRAP IS A BAD PUMP WHICH THREAD AMERICAN'S LIFE. FOLLOWING IS DYNAWRAP ON TREND MEDICAL LLC WEBSITE. HTTPS://WWW.TREND-MED.COM/PRODUCT/TREND-DYNAWRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178897 TREND DYNAWRAP PACK, HOT OR COLD, REUSABLE IME TREND MEDICAL, LLC E1399

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening TREND DYNAWRAP.