BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 93891 · Received May 21, 1997

    Report

    Report Number
    2020601-1997-00046
    Event Type
    Malfunction
    Date Received
    May 21, 1997
    Report Date
    May 20, 1997
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE INLET PIPE OF THE INSTRUMENT CAME OUT AND THE NURSE WAS INJURED. FOLLOW UP REPORT RECEIVED 5/20/97 STATED NURSE RECEIVED FACIAL CONTUSION AND CERVICAL SPRAIN. NO INJURY TO PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE DRILL REAMER HTO MICROAIRE SURGICAL INSTRUMENTS, INC. 7100-600 6B067

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN