BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIEZOSURGERY INCORPORATED

    MDR report key: 2777428 · Received September 27, 2012

    Report

    Report Number
    3005282635-2012-00001
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MECTRON S.P.A.
    Product Code
    ELC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY ((B)(6)) WAS PERFORMING AN UNKNOWN ORAL SURGERY PROCEDURE ON A PT USING A PIEZOSURGERY / DENTAL DEVICE. THE PT THEN COMPLAINED OF A SLIGHT BURN TO THIS SOFT TISSUE (LIP). COMPATIBLY, WITH IMPROPER USE OF THE DEVICE CONTRARY TO THE MANUFACTURER'S CLEARLY DEFINED GUIDELINES, THERE IS A POSSIBILITY OF DAMAGE TO SOFT TISSUE. FROM WHAT THE USER FACILITY HAS INFORMED US, THE INJURY WAS MINOR AND DID NOT CAUSE FOR ANY ADDITIONAL TREATMENT NOR HOSPITALIZATION. WE ARE ASSUMING THE WOUND HEALED ON ITS OWN. WE HAVE MADE SEVERAL ATTEMPTS TO GET MORE INFORMATION FROM THE USER FACILITY; HOWEVER, THEY ARE NOT COOPERATING. THEY CONTINUE TO NOT RETURN OUR CALLS/EMAILS. THEREFORE, AT THIS TIME, WE DO NOT HAVE SUFFICIENT INFORMATION TO DETERMINE WITH CERTAINTY WHETHER THE PT'S HARDSHIP WAS CAUSED BY THE PIEZOSURGERY / DENTAL DEVICE OR BY PHYSICIAN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIEZOSURGERY INCORPORATED PIEZOSURGERY // ELC MECTRON S.P.A. PIEZOSURGERY // N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A