BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS WATER BOTTLE

    MDR report key: 14279460 · Received May 4, 2022

    Report

    Report Number
    0002183416-2022-00001
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    January 14, 2022
    Report Date
    May 3, 2022
    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) 2022, THE COMPANY WAS AWARE THAT THE REPORT WAS NOT VISIBLE IN MAUDE DATABASE. AFTER ENQUIRING WITH FDA CDRH EMDR REPRESENTATIVE, WE LEARNED THERE WAS A TECHNICAL PROBLEM WHILE SUBMITTING THE FILE. THE COMPANY WAS ADVISED TO RESUBMIT THIS FORM AND TO ADD THIS STATEMENT. ON (B)(6) 2022, APOTHECARY PRODUCTS, LLC WAS NOTIFIED OF A POTENTIAL QUALITY ISSUE WITH ITEM 02816CV1 CVS WATER BOTTLE. OUR CUSTOMER RELATIONS REPRESENTATIVE CONTACTED (B)(6) WHO'S CONTACT INFORMATION WAS LISTED ON THE CVS INCIDENT FORM TO GET FURTHER DETAILS. USER FOLLOWED UP WITH IMAGES ON (B)(6) 2022. YOU PROVIDED ADDITIONAL DETAILS ON (B)(6) 2022, AS WELL AS NOTED THAT YOU NO LONGER HAVE THE WATER BOTTLE AS YOU RETURNED IT AND RECEIVED A NEW ONE. NEOSPORIN WAS APPLIED BUT NO MEDICAL INTERVENTION WAS REQUIRED. WE WOULD LIKE TO TAKE THIS OPPORTUNITY TO SINCERELY APOLOGIZE FOR ANY INCONVENIENCE AND DISCOMFORT YOU BOTH EXPERIENCED AND ALSO THANK YOU FOR BRINGING THIS MATTER TO OUR ATTENTION. PER YOUR EMAIL, IT WAS DETERMINED THAT THE WATER WAS HEATED ON THE STOVE BEFORE PUTTING IT IN THE BOTTLE. THE BOTTLE REMAINED INTACT AND THERE WAS NO LEAKAGE FROM THE BOTTLE. 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. PLEASE REFERENCE THE COMPLETE INSTRUCTIONS FOR USE AND WARNING STATEMENTS ON PAGE 2. YOUR COMMENTS AND FEEDBACK ARE AN IMPORTANT PART OF OUR QUALITY SYSTEM. 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 USER DID NOT FOLLOW PROPER DIRECTIONS FOR USE PRINTED ON THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565145 CVS WATER BOTTLE HOT WATER BOTTLE FPF APOTHECARY PRODUCTS LLC 02816CV1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female