BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YELLOFINS

    MDR report key: 2654735 · Received July 9, 2012

    Report

    Report Number
    MW5026121
    Event Type
    Injury
    Date Received
    July 9, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    ALLEN MEDICAL SYSTEMS INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    YELLOFINS STIRRUP LOCKING MECHANISM BROKE DURING SURGICAL CASE CAUSING AN EXTERNAL ROTATION TO OCCUR TO THE RIGHT HIP/LEG. BROKEN DEVICE REPLACED WITH A WORKING DEVICE. DATE OF USE: (B)(6) 2012 FOR APPROXIMATELY 15 MINUTES. REASON FOR USE: SURGICAL POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YELLOFINS SURGICAL STIRRUP FQO ALLEN MEDICAL SYSTEMS INC. LS0000

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention