BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX ANTERIOR

    MDR report key: 5208438 · Received November 6, 2015

    Report

    Report Number
    2125050-2015-00102
    Event Type
    Injury
    Date Received
    November 6, 2015
    Report Date
    October 26, 2015
    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. 11/06/2015: REPORT WAS DELAYED DUE TO AN ESG ISSUE. TICKET # (B )(4) WAS OPENED ON OCTOBER 30, 2015 AND WAS NOT RESOLVED UNTIL 11/06/2015.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WAS IMPLANTED WITH COMPETITOR'S PRODUCT, COLOPLAST RESTORELLE DFP AND RESTORELLE DFA ON (B)(6) 2011. LATER, THE PATIENT EXPERIENCED PAIN, SUFFERED DISABILITY, LOSS OF ENJOYMENT OF LIFE AND INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739185 RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH FTL COLOPLAST A/S 5014501400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other