BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAIR PRO - MODEL 6252

    MDR report key: 2932860 · Received December 28, 2012

    Report

    Report Number
    1831750-2012-13461
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CUSTOMER EVALUATED UNIT. TRACK FRAME. UNIT HAS BEEN REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRACK FRAME APPEARED TO TWISTED/SLIGHTLY BENT. MANUFACTURES INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAIR PRO - MODEL 6252 STRETCHER, HAND-CARRIED FPP STRYKER MEDICAL 6252 NA

    Patients

    Seq Age Sex Outcome Treatment
    1