BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 625251 · Received July 26, 2005

    Report

    Report Number
    625251
    Event Type
    Injury
    Date Received
    July 26, 2005
    Date of Event
    July 26, 2005
    Report Date
    July 26, 2005
    Manufacturer
    COREFLEX
    Product Code
    ITQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT, STATUS POST-OP FOR QUAD TENDON REPAIR, PRESENTED AT PHYSICIANS OFFICE FOR A SCHEDULED 2 WEEK POST-OP VISIT. PATIENT COMPLAINED OF FAILURE OF THE KNEE IMMOBILIZER. THREE METAL RODS ON POSTERIOR SURFACE OF THE KNEE IMMOBILIZER HAD PERFORATED THE FOAM PADDING. THE PATIENT COMPLAINED THAT METAL RODS WERE CUTTING INTO THEIR SKIN. THE PATIENT (A RETIRED ENGINEER) HAD IMPROVISED CLOTH PADDING TO PROTECT THEIR SKIN. THE MANUFACTURER ADVISED THAT SPECIFICATION FOR THAT DEVICE INCLUDES MUSLIN PADDING. THE PADDING APPEARED TO BE MISSING FROM THE DEVICE RECEIVED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON KNEE IMMOBILIZER ITQ COREFLEX 752451 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R