BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST

    MDR report key: 5776149 · Received July 7, 2016

    Report

    Report Number
    3004158247-2016-00001
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    May 2, 2016
    Report Date
    June 2, 2016
    Manufacturer
    SPECIALTY APPLIANCE WORKS, INC
    Product Code
    EJF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EACH DEVICE IS MANUFACTURED TO ORDER ACCORDING TO EACH PATIENTS' ANATOMY. AS SUCH, A DEVICE IS NOT TO BE USED BY DIFFERENT PATIENTS, BUT RATHER BY A SINGLE PATIENT FOR SEVERAL MONTHS. PLEASE NOTE THAT A PRODUCTION ACCOUNT FOR THE ELECTRONIC SUBMISSIONS GATEWAY (ESG) WAS INITIATED ON 6/7/2016. NOTIFICATION WAS RECEIVED ON 7/1/2016 THAT THE TEST SUBMISSION FAILED. A NEW TEST SUBMISSION WAS SENT ON 7/1/2016. THE PRODUCTION ACCOUNT WAS APPROVED ON 7/5/2016. THIS REPORT WAS IMMEDIATELY FILED ON 7/5/2016. NOTIFICATION WAS RECEIVED ON 7/7/2016 THAT THE SUBMISSION FAILED. A NEW SUBMISSION WAS SENT ON 7/7/2016.

    Description of Event or Problem · 1

    ON (B)(6) 2016, PATIENT'S PARENT NOTICED THAT A WIRE (.032" DIAMETER AND APPROXIMATELY 21 MM IN LENGTH) FROM THE EXPANDER WAS MISSING. THE PATIENT WAS NOT AWARE THAT THE WIRE CAME OFF AND IN ADVERTENTLY SWALLOWED THE WIRE. PATIENT WENT TO EMERGENCY ROOM TO SEEK MEDICAL ATTENTION. ON (B)(6), PATIENT RECEIVED A FOLLOW-UP X RAY. ON (B)(6), PATIENT WAS ADVISED THAT THE WIRE HAD PASSED AND WAS RELEASED. SUBSEQUENTLY ON (B)(6), PATIENT FELT A SHARP WIRE IN HER MOUTH. AN OCCLUSAL REST CAME OFF AND THE PATIENT SWALLOWED THE WIRE. PATIENT SOUGHT TREATMENT AT THE EMERGENCY ROOM. X RAYS WERE TAKEN TO LOCATE THE WIRE. THE WIRE WAS FOUND IN THE SMALL INTESTINE. PATIENT WAS ADVISED THAT WIRE WOULD PASS AND TO COME BACK IF SHE EXPERIENCED CRAMPING, BLEEDING OR PAIN. THE HERBST APPLIANCE WAS SEATED ON (B)(6) 2016 AND WAS REMOVED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430597 HERBST HERBST APPLIANCE EJF SPECIALTY APPLIANCE WORKS, INC 6469124

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention