BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATES GLIDDEN DRILL

    MDR report key: 1639377 · Received March 19, 2010

    Report

    Report Number
    8031010-2010-00031
    Event Type
    Injury
    Date Received
    March 19, 2010
    Report Date
    February 17, 2010
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    DZA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED IN THIS CASE, BECAUSE AN ENDOSCOPY PROCEDURE WAS PERFORMED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WHOLE GATES GLIDDEN DRILL WAS SWALLOWED BY A PT. AN ENDOSCOPY PROCEDURE WAS PERFORMED AND THE DEVICE WAS VISUALIZED IN THE SMALL INTESTINE, THOUGH COULD NOT BE ACCESSED FOR REMOVAL. THE PT WAS INFORMED THAT THE DEVICE COULD PROBABLY ONLY BE REMOVED SURGICALLY, THOUGH THE GASTROENTEROLOGIST DID NOT RECOMMEND THIS AND OPTED TO LEAVE THE DEVICE IN PLACE UNLESS ISSUES DEVELOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATES GLIDDEN DRILL DZA DENTSPLY TULSA DENTAL SPECIALTIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention