BEUDAMED
    FDA Adverse Event Summary report: N

    TEETHING PRODUCT FILLED WITH GEL-LIKE BEADS, ELEPHANT SHAPE

    MDR report key: 7494397 · Received May 7, 2018

    Report

    Report Number
    MW5077078
    Date Received
    May 7, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 25, 2018
    Manufacturer
    UNK
    Product Code
    KKO
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT IS A GEL BEAD-FILLED TEETHER. THE BEADS STARTED TO COME OUT. I KEPT THE PRODUCT TO TAKE PHOTOS AND REPORT IT. I CANNOT FIND THE PRODUCT ONLINE. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332188 TEETHING PRODUCT FILLED WITH GEL-LIKE BEADS, ELEPHANT SHAPE RING-TEETHING FLUID-FILLED KKO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO