BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2935942 · Received January 30, 2013

    Report

    Report Number
    0001831750-2013-00551
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PEDAL BROKEN WITH SHARP EDGES EXPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE PATIENT-LEFT SIDE CONTROL PEDAL WAS BROKEN. EXPOSED SHARP EDGES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40822 SM204 M-SERIES W/BIG WHEEL WHEELED, STRETCHER FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1