BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX ANT

    MDR report key: 4173974 · Received October 15, 2014

    Report

    Report Number
    2125050-2014-00414
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    July 11, 2013
    Report Date
    October 15, 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, ONE PATIENT WAS IMPLANTED WITH RESTORELLE DIRECTFIX ANTERIOR MESH. LATER THE PATIENT EXPERIENCED VAGINAL PAIN, DIFFICULTY EMPTYING BLADDER, HISTORY OF DIARRHEA, RECURRING CYSTOCELE AND RECTOCELE. AN OPEN SACROCOLPOPEXY WAS PERFORMED AND MEDICATIONS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655459 RESTORELLE DIRECTFIX ANT SURGICAL MESH FTL COLOPLAST A/S 5014501400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O