BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX POS

    MDR report key: 4017370 · Received August 18, 2014

    Report

    Report Number
    2125050-2014-00388
    Event Type
    Injury
    Date Received
    August 18, 2014
    Report Date
    August 13, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH RESTORELLE DIRECTFIX POSTERIOR AND ANTERIOR MESH. LATER THE PATIENT EXPERIENCED PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE AND INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES. NO EXPLANT PROCEDURE OR SUBSEQUENT TREATMENTS AND/OR THERAPIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493240 RESTORELLE DIRECTFIX POS SURGICAL MESH FTL COLOPLAST A/S 5014601400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other