BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 16CT

    MDR report key: 12214369 · Received July 22, 2021

    Report

    Report Number
    1825660-2021-00984
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 22, 2021
    Product Code
    OBR
    UDI-DI
    00651080651523
    PMA / PMN Number
    K094020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REVIEW POSTED ON (B)(6): SO DISAPPOINTED. ROLLS IN YOU MOUTH. VERY DIFFICULT TO KEEP IN PLACE. NOT FAIR TO RECEIVE A BAD PRODUCT THAT YOU MUST KEEP. AT NIGHT THEY SLIDE AROUND SO MUCH IT WAKES YOU AND THE SECOND NIGHT I WOKE UP CHOKING ON IT. POORLY MADE PRODUCT. NO PRODUCT RETURNED, NO CONTACT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111387 PLACKERS MTH GD GNM 16CT MOUTHGUARD, OVER-THE-COUNTER OBR MTH GD GNM 16CT 00651080651523

    Patients

    Seq Age Sex Outcome Treatment
    1