BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST APPLIANCE WIRONIT

    MDR report key: 7340873 · Received March 14, 2018

    Report

    Report Number
    MW5075874
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    March 1, 2017
    Report Date
    March 14, 2018
    Manufacturer
    BEGO U.S.A.
    Product Code
    EJH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED, ON BEHALF OF HER SON, TO REPORT ADVERSE EVENT INVOLVING AN HERBST APPLIANCE. THE REPORTER STATED THAT HER (B)(6) SON WAS WEARING THE DEVICE IN HIS MOUTH WHEN A SMALL PIECE BROKE OFF. THE REPORTER SAID HER SON SWALLOWED THE BROKEN PIECE AND IT WAS SEEN ON X-RAY IN HIS INTESTINES. REPORTER SAID THE PIECE WAS EVENTUALLY PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180922 HERBST APPLIANCE WIRONIT HERBST APPLIANCE WIRONIT EJH BEGO U.S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR