BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 8403836 · Received March 8, 2019

    Report

    Report Number
    1825660-2019-00522
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 8, 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 STATED SHE MAY HAVE SWALLOWED A PLACKERS GRIND NO MORE® DENTAL NIGHT GUARD. NO FURTHER INFORMATION RECEIVED FROM CONSUMER ABOUT WHETHER OR NOT SHE INDEED SWALLOWED THE GUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197101 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 14

    Patients

    Seq Age Sex Outcome Treatment
    1