BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 9401819 · Received December 3, 2019

    Report

    Report Number
    1825660-2019-00664
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    December 23, 2014
    Report Date
    December 3, 2019
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K094020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED "LAST NIGHT I BIT THROUGH MY GRIND NO MORE (ON THE SECOND NIGHT OF WEARING IT) AND WOKE UP AS I WAS SWALLOWING THE MIDDLE PART OF IT. THE TWO SIDE PARTS WERE STILL CLENCHED BETWEEN MY TEETH. REACHED OUT TO CONSUMER AND SHE DIDN'T RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199932 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT

    Patients

    Seq Age Sex Outcome Treatment
    1