BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 1933149 · Received December 13, 2010

    Report

    Report Number
    1831750-2010-04775
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIVISION
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE IS A BROKEN ZOOM COVER WITH EXPOSED SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM304 M-SERIES W/ZOOM WHEELED POWERED STRETCHER INK STRYKER CORP, MEDICAL DIVISION 1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA