BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIFROST

    MDR report key: 22016639 · Received May 14, 2025

    Report

    Report Number
    3011491271-2025-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 26, 2024
    Report Date
    February 14, 2025
    Manufacturer
    CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT BATCH NO OR SN WAS NOT PROVIDED, THE REPORTED PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND IT IS NOT EXPECTED THAT A PRODUCT WILL BE AVAILABLE FOR EVALUATION. IT IS NOT POSSIBLE FOR US TO ESTABLISH IF THERE WAS A MALFUNCTION INVOLVED IN THIS ALLEGED INCIDENT. THE MDR REPORTER SAYS "I ORDERED IT LAST MONTH IN AMAZON", THE EVENT DATE WAS APRIL THEN THE PURCHASE SHOULD HAPPEN IN MARCH, WE CONTACTED THE IMPORTER/SELLER SEVERAL TIMES TO INVESTIGATE THE CASE BASED ON THE SALES RECORD OF THAT TIME, NO VALID FEEDBACK WAS RECEIVED. WE REVIEWED 2 POSSIBLE PRODUCT BATCH RECORDS AND RAW MATERIAL RECORDS, NO ABNORMAL FINDINGS. THE POWER ADAPTOR SPECIATIONS AND TEST REPORT WERE CHECKED WITHOUT ABNORMAL FINDINGS, AND NO SIMILAR CUSTOMER FEEDBACK OF THE SAME PRODUCT WAS RECEIVED. FOR CURRENT AVAILABLE INFORMATION, WE CONCLUDE THAT THE INCIDENT WAS CAUSED BY IMPROPER OPERATION OF THE USER, OR THE REPORTED PRODUCT WAS NOT MANUFACTURED BY US. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN MORE EVIDENCE WAS COLLECTED.

    Description of Event or Problem · 0

    AN INCIDENT REPORT WAS LEARNED FROM MEDWATCH (REPORT NO MW5154615), IT WAS DESCRIBED AS: "REATHLETE MEDIFROST COLD THERAPY MACHINE IS A MEDICAL DEVICE BUT NO FDA. I ORDERED IT LAST MONTH IN AMAZON AND IT WAS GOOD WHEN I USED IT IN THE BEGINNING. BUT THE MAIN UNIT ELECTRIC LEAKAGE WHEN I ADD ICE TO THE BUCKET WHICH MAKES MY FINGERS INJURED. THE SELLER REATHLETE LLC SHOULDN'T GO ON SELL THIS MACHINE IN AMAZON IN CASE THREATENING MORE AMERICAN'S LIFE. REATHLETE LLC IS SELLING A MEDICAL DEVICE WITHOUT FDA IS ILLEGAL. PLEASE STOP REATHLETE SELLING IT. FOLLOWING IS REATHLETE LLC COLD THERAPY MACHINE AMAZON LINK..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880794 MEDIFROST COLD THERAPY SYSTEM ILO CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening