BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 26

    MDR report key: 2150237 · Received June 10, 2011

    Report

    Report Number
    1831750-2011-05790
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULT: IV POLE WELDMENT, PUSH HANDLE SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE IV POLE WELDMENT AND PUSH HANDLE SOCKET BOTH HAVE A CRACKED WELD, EXPOSING SHARP EDGES. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SERIES 26 HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1