BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEPLIT EASY STRIDER

    MDR report key: 2923259 · Received October 3, 2006

    Report

    Report Number
    1044691-2006-00001
    Event Type
    Injury
    Date Received
    October 3, 2006
    Date of Event
    July 6, 2006
    Report Date
    October 3, 2006
    Manufacturer
    FLA ORTHOPEDICS, INC.
    Product Code
    IOY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT RETURNED SUSPECT WALKER BRACE TO FLA ON (B)(6) 2006 FOR EVALUATION. FLA INSPECTED THE RIVET REPORTED TO BE THE CAUSE OF THE PRESSURE POINT ON THE PATIENT. SUSPECT RIVET IS USED TO HOLD CHAFING STRAP TO BOOT BODY AND WAS WITHIN SPECIFICATION. FELT PAD COVERING RIVET THAT HAD BEEN INSTALLED BY PHYSICIAN WAS PRESENT. THE FOAM/FABRIC LINER THAT IS PART OF THE BRACE WHICH PROTECTS THE FOOT FROM THE RIVET WAS IN PLACE AND SHOWED NO SIGNIFICANT ABRASION AT SUSPECT SITE. A REVIEW OF THE INSTRUCTIONS PROVIDED WITH THE WALKER BRACE REVEAL THAT THE BRACE IS INDICATED FOR SPRAINS, STRAINS AND STABLE FRACTURES. THIS PRODUCT IS NOT INDICATED FOR WOUND HEALING APPLICATIONS.

    Description of Event or Problem · 1

    PATIENT ("PT") IS A DIABETIC WITH CIRCULATION PROBLEMS IN LEFT LEG. PT DEVELOPED INFECTION IN BIG TOE OF LEFT FOOT IN EARLY 2006. PHYSICIAN PRESCRIBED A WALKER BOOT AS PART OF TREATMENT PLAN. PT DID NOT RESPOND TO TREATMENT. PHYSICIAN PUT LEFT FOOT IN A CAST. PT DEVELOPED HEEL ULCER ON LEFT FOOT. PHYSICIAN REMOVED CAST AND PRESCRIBED WALKER BRACE. ON (B)(6) 2006, PT PURCHASED SUBJECT WALKER BRACE AND BEGAN TO USE. ON (B)(6) 2006 PT NOTICED NEW SORE ON PINKY TOE OF LEFT FOOT. PHYSICIAN BRIDGED SUSPECT PRESSURE POINT IN BRACE WITH FELT PAD ON (B)(6) 2006. ON (B)(6) 2006, PT DISCONTINUED USE OF WALKER BRACE AND STARTED WEARING WALKER BOOT. ON (B)(6) 2006, PT HAD PINKY TOE ON LEFT FOOT AMPUTATED. ON (B)(6) 2006, PT CALLED FLA TO COMPLAIN THAT WALKER BRACE HAD A PRESSURE POINT CREATED BY A RIVET WHICH PT BELIEVES LED TO THE SORE THAT NECESSITATED THE AMPUTATION OF TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEPLIT EASY STRIDER WALKER BRACE IOY FLA ORTHOPEDICS, INC. 43-420

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability ANTIBIOTICS| WALKER| CAST| BOOT