BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARA WATER BOTTLE COMBINATION

    MDR report key: 297133 · Received September 21, 2000

    Report

    Report Number
    MW1019518
    Event Type
    Injury
    Date Received
    September 21, 2000
    Date of Event
    September 19, 2000
    Report Date
    September 21, 2000
    Manufacturer
    CARA, INC.
    Product Code
    FPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NEW BOTTLE OPENED AND THE SMELL OF RUBBER WAS SO STRONG THAT THE USER FELT THE NEED TO WASH IT FIRST. USER WASHED IT WITH WARM WATER AND THEN FILLED IT WITH HOT WATER. WITHIN A SHORT TIME THE USER WAS SO OVERCOME BY THE SMELL THAT THEY HAD TO GET THE BOTTLE OUT OF THE ROOM. THE RESIDUAL SMELL ON THE USER'S HANDS AND BED SHEETS WAS ALSO SO STRONG THEY HAD TO WASH THEIR CLOTHES/SHEETS AND HANDS. THE USER CALLED THE MFR, WHO REPLACED THE BOTTLE. WHEN THE USER OPENED THE NEW PACKAGE THEY NOTED THAT THE SMELL WAS STILL QUITE POTENT BUT NOT AS POTENT AS THE PREVIOUS BOTTLE. THE USER PLANS TO REPLACE THE BOTTLE WITH A DIFFERENT BRAND BUT QUESTIONS WHETHER IT IS A DEVICE PROBLEM OR PERHAPS AN ALLERGY THEY HAVE DEVELOPED. THEY REPORT NEVER HAVING HAD BREATHING DIFFICULTIES SUCH AS THIS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARA WATER BOTTLE COMBINATION RUBBER HOT WATER BOTTLE FPF CARA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR