BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS WATER BOTTLE

    MDR report key: 14256849 · Received April 29, 2022

    Report

    Report Number
    0002183-2022-00003
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    January 16, 2022
    Report Date
    April 29, 2022
    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 APRIL 5, 2022, (B)(6) NOTIFIED APOTHECARY PRODUCTS, LLC OF A POTENTIAL QUALITY ISSUE WITH ITEM 02816CV1 (B)(6) WATER BOTTLE. THE COMPLAINT ALLEGED THAT THE WATER BOTTLE LEAKED, AND THE CONSUMER, EXPERIENCED BURNS ON HER RIGHT BUTTOCKS. IT WAS REPORTED THAT SHE WENT TO (B)(6) AND WAS TREATED. THE WATER WAS HEATED IN A KETTLE BEFORE PUTTING IT IN THE WATER BOTTLE BY THE CUSTOMER. THIS IS CONTRA TO THE INSTRUCTIONS FOR SAFE USE PROVIDED WITH THE PRODUCT. IT IS IMPORTANT TO NOTE THAT THE GENERAL INSTRUCTIONS AND WARNINGS ON THE PACKAGING PROVIDED WITH THE PRODUCT INCLUDE THE FOLLOWING INFORMATION FOR SAFE USE: INSTRUCTIONS FOR USE: FILL BOTTLE TWO-THIRDS WITH PLAIN WARM TAP WATER ONLY. LET OUT EXCESS AIR BEFORE THREADING IN STOPPER. THREAD STOPPER INTO BOTTLE. MAKE SURE STOPPER IS IN SECURELY. DO NOT OVERTIGHTEN. TEST FOR LEAKAGE BY TURNING BOTTLE UPSIDE DOWN AND PRESSING FIRMLY. WARNINGS/CAUTION: FLUID SHOULD NOT EXCEED 120°F (48.9°C) FOR HOT WATER BOTTLE USE. CAREFULLY EXAMINE BOTTLE BEFORE EACH USE. IF IT SHOWS SIGNS OF WEAR (CRACKS, DRYNESS, BUBBLES, ETC.), IT SHOULD BE DISCARDED. DO NOT USE MICROWAVE, CONVENTIONAL OVEN, OR STOVETOP TO HEAT VESSEL OR WATER. FOR APPLICATION TO SENSITIVE SKIN AREAS, WRAP SOFT CLOTH OR TOWEL AROUND BOTTLE. APOTHECARY PRODUCTS REGULARLY MONITORS ALL CUSTOMER FEEDBACK TO ENSURE THAT WE TAKE QUICK ACTION TO RESOLVE OUR CUSTOMERS' CONCERNS. APOTHECARY PRODUCTS IS COMMITTED TO PROVIDING THE HIGHEST QUALITY PRODUCTS TO OUR CUSTOMERS.

    Description of Event or Problem · 0

    THE CUSTOMER CLAIMED TO HAVE GOT BURNED USING HOT WATER BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144220 CVS WATER BOTTLE HOT WATER BOTTLE FPF APOTHECARY PRODUCTS LLC 02816CV1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization