BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUATE

    MDR report key: 1929708 · Received December 14, 2010

    Report

    Report Number
    MW5018582
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Product Code
    MNE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER APPLIED SPACERS ON (B)(6) 2010 AND SAID WHEN HE REMOVED SPACERS ON (B)(6) 2010 THE SPACER WAS HARD TO REMOVE DUE TO A STICKY SUBSTANCE ON THE SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUATE TOE SPACERS (GEL) MNE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR