BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERBST APPLIANCE

    MDR report key: 6768155 · Received August 4, 2017

    Report

    Report Number
    3004158247-2017-00001
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 4, 2017
    Manufacturer
    SPECIALTY APPLIANCE WORKS, INC
    Product Code
    ECN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCTOR'S OFFICE ALLEGED THAT A PATIENT SWALLOWED A HERBST APPLIANCE SCREW. UPON INITIAL REPORT, THE MOTHER CONFIRMED THAT THE PATIENT PASSED THE SCREW. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION TO REMOVE THE SCREW. NO COMPLICATIONS OR ADVERSE SYMPTOMS HAVE BEEN NOTED. THE DOCTOR REQUESTED A REPLACEMENT SCREW. THE PATIENT IS CONTINUING TREATMENT WITH THE ORIGINAL APPLIANCE AND THE REPLACEMENT SCREW. THE APPLIANCE WAS NOT RETURNED SO AN EVALUATION COULD NOT BE PERFORMED. THE REPORT WAS FILED AS A MALFUNCTION AS A PRECAUTION DUE TO LACK OF INFORMATION.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT A PATIENT SWALLOWED A HERBST APPLIANCE SCREW. UPON INITIAL REPORT, THE MOTHER CONFIRMED THAT THE PATIENT PASSED THE SCREW. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION TO REMOVE THE SCREW. NO COMPLICATIONS OR ADVERSE SYMPTOMS HAVE BEEN NOTED. THE DOCTOR REQUESTED A REPLACEMENT SCREW. THE PATIENT IS CONTINUING TREATMENT WITH THE ORIGINAL APPLIANCE AND THE REPLACEMENT SCREW. THE APPLIANCE WAS NOT RETURNED SO AN EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549725 HERBST APPLIANCE HERBST SCREW ECN SPECIALTY APPLIANCE WORKS, INC 6640075

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR