BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEE CARE DIGITAL PACIFIER/THERMOMETER

    MDR report key: 32179 · Received April 23, 1996

    Report

    Report Number
    MW4001151
    Event Type
    Malfunction
    Date Received
    April 23, 1996
    Report Date
    March 12, 1996
    Manufacturer
    QUESTECH INTL, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    QUESTECH INTL, INC. STE 238, 4951-B E ADAMO DR, TAMPA, FL 33605. WE RECEIVED PRODUCT RETURNS FROM HSN, BUT NONE THAT COULD BE IDENTIFIED AS MS HAVRANEK'S. THEREFORE, WE HAVE NO TESTING WHICH RELATED TO THE SPECIFIC DEVICE USED BY MS HAVRANEK. THE DEVICE WAS TESTED PER CONSUMER PRODUCT SAFETY COMMISSION REQUIREMENTS FOR PACIFIERS (16 CFR, CH.11 PART 1511), WHICH INCLUDES A STRUCTURAL INTEGRITY TEST FOR THE NIPPLE. IT PASSED TESTS BY AN INDEPENDENT TESTING AGENCY PRIOR TO SUBMISSION FOR OUR FDA 510 (K). SUBSEQUENT TO FDA CLEARANCE TO MARKET, CPSC TOOK INVENTORY FROM OUR TAMPA WAREHOUSE TO TEST IN THEIR OWN LABS. AGAIN, WE PASSED THE NIPPLE PULL TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEE CARE DIGITAL PACIFIER/THERMOMETER DIGITAL THERMOMETER FLL QUESTECH INTL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO