BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSTAT STERNAL SAW

    MDR report key: 74806 · Received March 7, 1997

    Report

    Report Number
    2219689-1997-00151
    Event Type
    Malfunction
    Date Received
    March 7, 1997
    Date of Event
    February 5, 1997
    Report Date
    March 6, 1997
    Manufacturer
    SURGIQUIP, INC.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SAW WAS NOT STERILE UPON OPENING. THIS EVENT OCCURRED PRIOR TO SURGERY, THEREFORE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSTAT STERNAL SAW INSTRUMENT DWH SURGIQUIP, INC. NA 0696SHP01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA