BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE WEE SOOTHER

    MDR report key: 355300 · Received August 21, 2001

    Report

    Report Number
    MW4003122
    Event Type
    Malfunction
    Date Received
    August 21, 2001
    Date of Event
    August 1, 2001
    Report Date
    August 21, 2001
    Manufacturer
    CHILDREN'S MEDICAL VENTURES
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    OILY FILM ALL OVER THE PACIFIER. TOOK IT BACK AND WAS GIVEN ANOTHER ONE, SAME PROBLEM. THE OILY FILM COULD NOT BE WIPED-OFF.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/2/01: IN RESPONSE TO THE MEDWATCH REPORT, MFR IMMEDIATELY CONTACT SUPPLIER, A MOLDING OPERATION. THE RESPONSE CONFIRMED THAT THERE ARE NO OILS USED IN THE MOLDING AND PACKAGING OF THE PACIFIERS. SINCE THERE ARE NO AVAILABLE PARTS (PACIFIERS WITH REPORTED OIL), MFR IS UNABLE TO INVESTIGATE THIS CLAIM ANY FURTHER. IN SUPPORT OF FIRM'S BELIEF THAT THIS REPORT IS NOT REFLECTIVE OF ITS STYLE PACIFIERS, MFR SUBMITS THE FOLLOWING; CHILDREN'S MEDICAL VENTURES HAS DISTRIBUTED IN EXCESS OF 5 MILLION PACIFIERS (ALL TYPES) IN THE PAST TWO YEARS WITHOUT ANY REPORT OF OIL OR SIMILAR CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38453 THE WEE SOOTHER PACIFIER LQX CHILDREN'S MEDICAL VENTURES NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO