BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC PEN DRIVE

    MDR report key: 2956263 · Received February 7, 2013

    Report

    Report Number
    8030965-2013-10060
    Event Type
    Injury
    Date Received
    February 7, 2013
    Report Date
    March 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL COMMON DEVICE NAMES ARE AS FOLLOWS: DZI, ERL, HBE. FULL LOT NUMBER REPORTED AS 1045/5545187. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. REPORTED ISSUE WAS CONFIRMED. DEVICE HAS BEEN REPAIRED AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A WISDOM TEETH REMOVAL PROCEDURE, THE ELECTRIC PEN DRIVE OVERHEATED, THE DOCTOR COULD NOT HOLD ON TO IT. DOCTOR WAS UNABLE TO MOVE THE DEVICE FAST ENOUGH AND BURNED THE PT'S UPPER LEFT LIP AND LOWER RIGHT LIP NEAR THE CORNERS OF THE MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51432 ELECTRIC PEN DRIVE HWE SYNTHES GMBH 1045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention