BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRACTURE WALKER

    MDR report key: 1063408 · Received June 19, 2008

    Report

    Report Number
    2242816-2008-00094
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 21, 2008
    Report Date
    June 16, 2008
    Manufacturer
    EBI
    Product Code
    IQI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MATERIAL INFORMATION USED IN THE LINER WAS REVIEWED. THE FABRIC OF THE LINER IS THE COMPONENT THAT COMES IN CONTACT WITH THE SKIN. THE MANUFACTURER REPORTED THE FABRIC TO BE 100% NYLON FABRIC. THE MANUFACTURER PROVIDED A CERTIFICATE STATING THAT THE 100% NYLON FABRIC HAS BEEN SUCCESSFULLY TESTED FOR HARMFUL SUBSTANCES IN ACCORDANCE WITH THE REQUIREMENTS OF OEKO-TEX STANDARD 100 FOR DIRECT CONTACT WITH SKIN. OEKO-TEX STANDARD 100 EVALUATES AND SCREENS FOR ANY HARMFUL SUBSTANCES PRESENT WITHIN PROCESSED TEXTILES INTENDED TO COME INTO CONTACT WITH CONSUMERS. A COPY OF THE CERTIFICATE IS ATTACHED. REVIEW OF PRODUCT COMPLAINT AND SALES HISTORY FOR RELATED PRODUCT FROM JANUARY 2006 THROUGH JULY 2008 DETERMINED THAT THIS IS THE 1ST REPORTED EVENT OF SKIN REACTION. ATTACHMENT: [2008-00094 SUPP 1 ATTACH.PDF, FDA REQUEST.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD ALLERGIC CONTACT DERMATITIS TO THE LINER OF THE FRACTURE WALKER AT THE AREA OF INCISION SITES AND THE AREA OF ACTIVE HEALING TRAUMA (FRACTURE) BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRACTURE WALKER IQI EBI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention