BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSTAT OSCILLATING SAW

    MDR report key: 87876 · Received April 28, 1997

    Report

    Report Number
    2219689-1997-00216
    Event Type
    Malfunction
    Date Received
    April 28, 1997
    Date of Event
    April 4, 1997
    Report Date
    April 24, 1997
    Manufacturer
    SURGIQUIP, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FRONT PART OF THE PLASTIC CASING BROKE USE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSTAT OSCILLATING SAW INSTRUMENT HWE SURGIQUIP, INC. NA 07940S02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other