BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 10CT

    MDR report key: 9677216 · Received February 6, 2020

    Report

    Report Number
    1825660-2020-00701
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 6, 2020
    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 THE "GUARDS HAVE SHARP EDGES, A BIT MORE THICKER AND A STRONGER CHEMICAL SMELL. I'M NOTICING THAT MY TONGUE IS SWELLING UP AND NOT SURE WHY." BASED ON EVENT DESCRIPTION, MAY BE AN ALLERGIC REACTION. NO CONTACT INFORMATION PROVIDED, PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143045 PLACKERS MTH GD GNM 10CT MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT

    Patients

    Seq Age Sex Outcome Treatment
    1