BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST APPLIANCE

    MDR report key: 7282634 · Received February 20, 2018

    Report

    Report Number
    3004158247-2018-00001
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    March 23, 2017
    Report Date
    January 26, 2018
    Manufacturer
    SPECIALTY APPLIANCE WORKS, INC
    Product Code
    ECN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, SPECIALTY APPLIANCES RECEIVED A LETTER FROM A PATIENT'S PARENT STATING THAT HER SON SWALLOWED A BROKEN PART FROM A HERBST APPLIANCE. THE LETTER STATED THAT THE INCIDENT OCCURRED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS SEEN IN THE EMERGENCY ROOM. AN X-RAY SHOWED A METALLIC STRUCTURE OVERLYING THE UPPER RIGHT QUADRANT OF THE ABDOMEN. ON (B)(6) 2017 THE PATIENT DEVELOPED A FEVER AND STOMACH CRAMPS. ON (B)(6) 2017 A SECOND X-RAY WAS TAKEN AND IT WAS CONFIRMED THAT THE METALLIC STRUCTURE PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126452 HERBST APPLIANCE HERBST APPLIANCE ECN SPECIALTY APPLIANCE WORKS, INC 6526811

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention