BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAICE

    MDR report key: 21596579 · Received March 13, 2025

    Report

    Report Number
    MW5167652
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    March 10, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ULTRA PAIN PRODUCTS, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I GOT ULTRAICE IN JANUARY. THE DEVICE IS A LITTLE LEAKING BUT I IGNORE IT. KNEE WRAP EXPLODED WHEN I USED IT LAST WEEK, WATER FROM KNEE WRAP MADE MY BANDAGE WET. MY KNEE HAS A RISK OF INFECTION. MEDICAL DEVICE WITHOUT MANUFACTURER CONTACT IS ILLEGAL. FOLLOWING IS ULTRAICE LINK: HTTPS://ULTRAPAINPRO.COM/PRODUCTS/#ULTRA-ICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986716 ULTRAICE PACK, HOT OR COLD, WATER CIRCULATING ILO ULTRA PAIN PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Life Threatening