BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 8524725 · Received April 17, 2019

    Report

    Report Number
    1825660-2019-00539
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 17, 2019
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K094020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED AND ASKED IF PEOPLE HAVE EVER SWALLOWED THE GRIND NO MORE GUARD BECAUSE SHE CAN'T FIND IT IN HER ROOM THIS MORNING. CONSUMER WAS NOT ABLE TO CONFIRM WHETHER OR NOT SHE SWALLOWED THE GUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317864 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT

    Patients

    Seq Age Sex Outcome Treatment
    1