BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DO NOT USE-SURGICAL DRILL UNIT, 100-130V

    MDR report key: 7791088 · Received August 16, 2018

    Report

    Report Number
    0001038806-2018-00755
    Event Type
    Injury
    Date Received
    August 16, 2018
    Report Date
    August 16, 2018
    Manufacturer
    W&H IMPEX INC
    Product Code
    EBW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR OCCURRED DURING THE PROCEDURE WITH THE DRILL. ANOTHER TOOL COULD NOT BE USED AND THE PATIENT HAD TO COME BACK TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632938 DO NOT USE-SURGICAL DRILL UNIT, 100-130V DENTAL DRILL UNIT EBW W&H IMPEX INC 02210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention