BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 20623414 · Received November 6, 2024

    Report

    Report Number
    0002183416-2024-00001
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    September 10, 2023
    Report Date
    November 6, 2024
    Manufacturer
    APOTHECARY PRODUCTS LLC.
    Product Code
    FPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6), 2024 APOTHECARY PRODUCTS LLC WAS NOTIFIED OF AN ELLEGED EVENT THAT OCCUR ON (B)(6), 2023. FROM THE COMMUNICATION THAT OUR COMPANY HAD WITH THE CLAIMS ADJUSTOR APOTHECARY PRODUCTS LLC IDENTIFIED THAT THE USER DID NOT FOLLOW THE CORRECT INSTRUCTIONS FOR USE PROVIDED ON THE DEVICE LABEL AND ENBOSED ON THE DEVICE. IT IS IMPORTANT TO NOTICE THAT THE INSTRUCTIONS AND THE WARNINGS ON THE PACKAGING INCLUDE THE FOLLOWING: - FOR WARM APPLICATION FILL WATER 2/3 WITH PLAIN WARM TAP WATER ONLY - FLUID SHOULD NOT EXCEED 120OF FOR HOT WATER BOTTLE USE - DO NOT USE MICROWAVE, CONVENTIONAL OVEN OR STOVE TOP TO HEAT VESSEL OR WATER -FOR APPLICATION TO SENSITIVE AREAS, WRAP SOFT CLOTH AROUND BOTTLE - IN ADDITION TO THE PACKAGING, ON THE NECK TO THE BOTTLE THERE IS A WATER TEMPERATURE WARNING: DO NOT EXCEED 120OF.

    Description of Event or Problem · 0

    CUSTOMER ALLEGEDLY BOUGH A HOT WATER BOTTLE FROM WALGREENS, MANUFACTURED BY APOTHECARY PRODUCTS LLC. HE USED THE DEVICE AND BURN HIS FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998940 WALGREENS BOTTLE, HOT/COLD WATER FPF APOTHECARY PRODUCTS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other