BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOE DH OFFLOAD MD

    MDR report key: 6245849 · Received January 12, 2017

    Report

    Report Number
    2085446-2017-00001
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    November 9, 2016
    Report Date
    March 9, 2017
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IPG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FDA MEDWATCH REPORT RECEIVED INDICATING: THE TOP CAP SEAM CAUSED ABRASIVE PRESSURE RESULTING IN A BLISTER. THE PATIENT VISITED THE DOCTOR AND MEDICATIONS WERE PROVIDED TO TREAT THE ULCER BUT EVENTUAL AMPUTATION OF THE 5TH METATARSAL AND 5TH TOE WAS NEEDED. THERE WAS NO INDICATION OF THE ORIGINAL FITTING FO THE DH OFFLOADING SHOE.

    Description of Event or Problem · 1

    FDA MEDWATCH REPORT RECEIVED INDICATING: THE TOP CAP SEAM CAUSED ABRASIVE PRESSURE RESULTING IN A BLISTER. THE PATIENT VISITED THE DOCTOR AND MEDICATIONS WERE PROVIDED TO TREAT THE ULCER BUT EVENTUAL AMPUTATION OF THE 5TH METATARSAL AND 5TH TOE WAS NEEDED. THERE WAS NO INDICATION OF THE ORIGINAL FITTING FO THE DH OFFLOADING SHOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30645 SHOE DH OFFLOAD MD SHOE CAST IPG OSSUR AMERICAS 10341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention