BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1021514 · Received March 31, 2008

    Report

    Report Number
    MW5006049
    Date Received
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    MEDEL DEVELOPMENT
    Product Code
    LQX
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MOTHER OF A CHILD CALLED TO REPORT THAT AFTER 10 DAYS USING THE DEVICE, HER CHILD CHEWED IT, AND IT IS UNKNOWN IF THE FRAGMENTED PIECE WAS SWALLOWED OR NOT. SHE STATED THAT HER CHILD NEEDS TO WEAR THIS DEVICE 24 HR/DAY FOR 3-4 WEEKS TO GET THE RESULTS WHICH IS TO HELP HER STOP SUCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FINGER SUCKING DEVICE LQX MEDEL DEVELOPMENT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR