BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANVAS ROCKER CAST & SANDAL, LARGE

    MDR report key: 167687 · Received May 13, 1998

    Report

    Report Number
    1037420-1998-00001
    Event Type
    Malfunction
    Date Received
    May 13, 1998
    Date of Event
    April 13, 1998
    Report Date
    May 12, 1998
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    FXW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TOE STRAP STITCHING OF THE CAST SHOE DETACHED WHILE A PT WAS WEARING DEROYAL CASE SHOE WITH A SHORT WALKING CAST. THE PT FELL, DISLOCATING HER SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANVAS ROCKER CAST & SANDAL, LARGE CAST SHOE FXW DEROYAL INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR