BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2922992 · Received January 18, 2013

    Report

    Report Number
    0001831750-2013-00196
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS MDR WAS FILED AS A DUPLICATED MDR OF 0001831750-2013-00194. MDR 0001831750-2013-00194 WAS PREVIOUSLY FILED ON (B)(4). SEE MDR 0001831750-2013-00194 FOR ADDITIONAL DETAILS REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL COULD POTENTIALLY BECOME UNLATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL COULD POTENTIALLY BECOME UNLATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27582 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1015

    Patients

    Seq Age Sex Outcome Treatment
    1