BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 90747 · Received May 6, 1997

    Report

    Report Number
    2020601-1997-00055
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    April 4, 1997
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A SURGICAL EXTRACTION OF A MOLAR, IT WAS REPORTED THAT THE PT'S LIP WAS BURNED. THE DEGREE OF BURN WAS NOT NOTED. THE DOCTOR TREATED THE BURN WITH NEOSPORIN. FURTHER CONTACT WITH THE DOCTOR NOTED THE PT'S LIP IS HEALING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE HI-SPEED DRILL DZA MICROAIRE SURGICAL INSTRUMENTS, INC. 2910-300 2N648

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR