BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    KELVI

    MDR report key: 15919839 · Received December 5, 2022

    Report

    Report Number
    3015252349-2022-00001
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    November 15, 2021
    Report Date
    December 5, 2022
    Manufacturer
    HYPOTHERMIA DEVICES INC.
    Product Code
    ILO
    UDI-DI
    00850001185059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATHLETE DEVELOPED A BLISTER APPROXIMATELY ONE INCH IN DIAMETER ON THE LATERAL PART OF THE RIGHT ANKLE WHILE USING A CONTRAST PROTOCOL. THE BLISTER HEALED FULLY AND THE PATIENT REQUIRED NO OUTSIDE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899697 KELVI ANKLE PRO SMART WRAP ILO HYPOTHERMIA DEVICES INC. ASM-0109 2038 00850001185059

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other PRO CONSOLE, ASM-0029| UMBILICAL, ASM-0100