BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2954766 · Received February 11, 2013

    Report

    Report Number
    0001831750-2013-00949
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    March 12, 2012
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COVERS ON THE STRETCHER WERE BROKEN RESULTING IN THE EXPOSURE OF SHARP EDGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COVERS ON THE STRETCHER WERE BROKEN RESULTING IN THE EXPOSURE OF SHARP EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58969 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 1025

    Patients

    Seq Age Sex Outcome Treatment
    1