BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 8515710 · Received April 15, 2019

    Report

    Report Number
    1825660-2019-00537
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 15, 2019
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER CLAIMED HE/SHE SWALLOWED THE GRIND NO MORE. HE WENT TO HIS DOCTOR AND SHOWED THE SAME PRODUCT TO THE DOCTOR, AND HE TOLD ME "EASY AND WAITING FOR IT EXHAUST." CONSUMER DIDN'T CONFIRM IF THE GUARD WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309392 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT 27029

    Patients

    Seq Age Sex Outcome Treatment
    1