BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN SCREW POST KEYS

    MDR report key: 939584 · Received October 26, 2007

    Report

    Report Number
    2411236-2007-21952
    Event Type
    Injury
    Date Received
    October 26, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 10, 2007
    Manufacturer
    HARALD NORDIN SA/ MECODONT
    Product Code
    ELR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A MALE PATIENT WAS HAVING A ROOT CANAL AND CROWN PREP PROCEDURE. DURING THIS PROCESS THE PATIENT HIT THE SCREWDRIVER WITH HIS TONGUE AND HE KNOCKED THE SCREWDRIVER AND THE SCREW DOWN HIS THROAT WHICH WAS SWALLOWED. THE SCREWDRIVER WAS PART OF THIS KIT. THE PATIENT DID NOT HAVE ANY REACTION AT THE TIME THE ITEMS WERE SWALLOWED. HE WAS TAKEN IMMEDIATELY TO THE ER WHERE THE PATIENT UNDERWENT TWO X-RAYS. THE PATIENT BEGAN TO VOMIT AND HAD DIARRHEA WHICH THE ER PHYSICIAN FELT WAS NORMAL DUE TO THE EVENT OF SWALLOWING THESE ITEMS. NO OTHER TREATMENT WAS ADMINISTERED. BOTH ITEMS WERE IN THE PATIENT'S STOMACH AT THE TIME OF THE LAST X-RAY. OUR ACCOUNT CLAIMS THAT THE ER PHYSICIAN EXPECTS THAT HE WILL PASS BOTH ITEMS NATURALLY. ON FRIDAY 19TH OF OCTOBER, IMP WAS ADVISED THAT THE PATIENT HAD PASSED THE SWALLOWED PIECES NATURALY WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN SCREW POST KEYS SCREW POST KEYS ELR HARALD NORDIN SA/ MECODONT * 05714/220

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization