BEUDAMED
    FDA Adverse Event Injury Summary report: N

    W & H IMPLANTMED DRILLING UNIT WHITE MODEL SI-915, 2011

    MDR report key: 7806338 · Received August 22, 2018

    Report

    Report Number
    0001038806-2018-00777
    Event Type
    Injury
    Date Received
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    W&H IMPEX INC
    Product Code
    EBW
    PMA / PMN Number
    PK052741
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILLING UNIT (16929001) IS OVERHEATING, WON'T TURN, AND WON'T SPRAY WATER. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS THE DOCTOR WAS WITH A PATIENT IN THE MIDDLE OF TREATMENT AND THE DEVICE MALFUNCTIONED. THE PATIENT WILL HAVE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647599 W & H IMPLANTMED DRILLING UNIT WHITE MODEL SI-915, 2011 DENTAL DRILL UNIT EBW W&H IMPEX INC 06631600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention