BEUDAMED
    FDA Adverse Event Summary report: N

    READY TO WEAR DENTAL PROTECTOR

    MDR report key: 5144492 · Received October 12, 2015

    Report

    Report Number
    1825660-2015-00056
    Date Received
    October 12, 2015
    Date of Event
    September 16, 2015
    Report Date
    October 9, 2015
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DEVICE UNATTENDED

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT HE HAS BELLY ACHES WHEN HE WAKES UP AND WONDERS IF HE SWALLOWED THE MOUTHGUARD OR IF HE HAS CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675103 READY TO WEAR DENTAL PROTECTOR BRUXISM DEVICE OBR RANIR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other