BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-1 COT - BASE HIGH LOAD 28

    MDR report key: 3212578 · Received July 9, 2013

    Report

    Report Number
    0001831750-2013-06170
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETAINING POST WAS BROKEN WHICH COULD AFFECT THE COT FASTENING TO THE FASTENER. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313386 M-1 COT - BASE HIGH LOAD 28 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1