BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE EZA 6X4CM

    MDR report key: 2189877 · Received August 3, 2011

    Report

    Report Number
    2125050-2011-00004
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 7, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. WITHOUT THE BENEFIT OF REVIEW AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THE PHYSICIAN STATED HE IS HAVING PROBLEMS WITH MPATHY MESH AND EROSION WHERE HE CUT THE MESH IN HALF FOR ANTERIOR REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORELLE EZA 6X4CM SURGICAL MESH FTL COLOPLAST A/S 5013401400 2842242

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R