BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODHEALTH BOTTLE (HOT WATER BOTTLE)

    MDR report key: 534371 · Received March 15, 2004

    Report

    Report Number
    1520456-2004-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 20, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D OF A WATER BOTTLE THAT LEAKED WHILE IN USE. THE CONSUMER REPORTED THAT THEY PLACED THE WATER BOTTLE ON THEIR BACK. PT THEN NOTED THAT IT HAD "GOTTEN THEIR BED ALL WET." THE CONSUMER REPORTED THAT THE LEAK WAS FROM THE "PLUG" OF THE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODHEALTH BOTTLE (HOT WATER BOTTLE) HOT WATER BOTTLE FPF ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other