BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS WATER BOTTLE

    MDR report key: 17004157 · Received May 25, 2023

    Report

    Report Number
    0002183416-2023-00001
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 6, 2023
    Report Date
    May 25, 2023
    Manufacturer
    APOTHECARY PRODUCTS LLC
    Product Code
    FPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, APOTHECARY PRODUCTS, LLC WAS NOTIFIED OF A POTENTIAL ISSUE WITH ITEM 02814WG3 WALGREENS WATER BOTTLE. FROM THE COMMUNICATION WITH THE USER IT WAS DETERMINED THAT THE USER DID NOT FOLLOW INSTRUCTIONS FOR USE PROVIDED ON DEVICE LABEL TO HEAT THE WATER. IT IS IMPORTANT TO NOTE THAT THE INSTRUCTIONS AND WARNINGS ON THE PACKAGING INCLUDE THE FOLLOWING: FOR WARM APPLICATION, FILL BOTTLE TWO-THIRDS WITH PLAIN WARM TAP WATER ONLY. FLUID SHOULD NOT EXCEED 120°F (48.9°C) FOR HOT WATER BOTTLE USE. DO NOT USE MICROWAVE, CONVENTIONAL OVEN OR STOVETOP TO HEAT VESSEL OR WATER. FOR APPLICATION TO SENSITIVE SKINS AREAS, WRAP SOFT CLOTH OR TOWEL AROUND BOTTLE. IN ADDITION TO THE PACKAGING, THERE IS A TEMPERATURE WARNING ON THE NECK OF THE BOTTLE.

    Description of Event or Problem · 0

    THE USER DID NOT FOLLOW PROPER DIRECTIONS FOR USE PRINTED ON THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666378 WALGREENS WATER BOTTLE HOT WATER BOTTLE FPF APOTHECARY PRODUCTS LLC 02814WG3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown