BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MOTOR

    MDR report key: 12436924 · Received September 7, 2021

    Report

    Report Number
    1625507-2021-00302
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    September 1, 2018
    Report Date
    September 7, 2021
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS TO CHECK THE DEVICE FOR DAMAGE BEFORE USE. IF DAMAGE IS FOUND, THE DEVICE SHOULD NOT BE USED. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. PMA / 510(K) #: NO INFORMATION AVAILABLE ON DEVICE TO CONFIRM APPLICABLE 510(K). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NASAL DERMOID EXCISION PROCEDURE, THE DRILL CAUSED A SEVERE FULL THICKNESS BURN ON THE PATIENT'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329863 UNKNOWN MOTOR MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS UNKNOWN MOTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other