BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODY COMFORT

    MDR report key: 8740005 · Received June 26, 2019

    Report

    Report Number
    MW5087668
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 1, 2019
    Report Date
    June 3, 2019
    Manufacturer
    UNK
    Product Code
    IMA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TRIED BOILING IT EXACTLY AS INDICATED ON THE DIRECTIONS. IT BURST THE "MEDICAL GRADE" HOT PACK. CALLED CUSTOMER SERVICE. I TOLD HIM THAT THE SUBSTANCE IRRITATED MY HAND CAUSING A BURNING SENSATION IN THE FINGERS FOR A COUPLE OF HOURS. HE KEPT SAYING THAT THE SOLUTION WAS NOTHING BUT SAFE SALT WATER. THE SALT INGREDIENT THAT THEY CALL "SALT" WATER IS SODIUM ACETATE, NOT A NORMAL SALINE (SALT) SOLUTION WHICH IS MADE FROM SODIUM CHLORIDE. THIS INFO CAN BE FOUND ON THE WEBSITE: (B)(6); THE FOLLOWING IS COPIED FROM THE SAFETY DATA SHEET: MATERIAL MAY BE IRRITATING TO THE MUCOUS MEMBRANES AND UPPER RESPIRATORY TRACT. MAY BE HARMFUL BY INHALATION, INGESTION, OR SKIN ABSORPTION. MAY CAUSE SKIN OR RESPIRATORY SYSTEM IRRITATION. TO THE BEST OF OUR KNOWLEDGE, THE TOXICOLOGICAL PROPERTIES HAVE NOT BEEN THOROUGHLY INVESTIGATED. I DO NOT SEE IT BEING A SAFE PRODUCT IN THE EVENT THAT THE PRODUCT VERY EASILY BURSTS AND "THE TOXICOLOGICAL PROPERTIES HAVE NOT BEEN THOROUGHLY INVESTIGATED." I FIND IT INCREDIBLY MISLEADING FOR A CUSTOMER SERVICE PERSONNEL TO CONTINUE TO SAY THE SUBSTANCE IS A SAFE SALT WATER MIXTURE. (B)(4). PURCHASE DATE: (B)(6) 2019. INNOVAGE LLC. CALLED THE MFR ON JUNE 3, 2019. INDICATED THAT THE SUBSTANCE WAS SAFE FOR HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531599 BODY COMFORT PACK, HOT, MOIST IMA UNK 1656641

    Patients

    Seq Age Sex Outcome Treatment
    1 33 WK