BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX POS

    MDR report key: 5980126 · Received September 27, 2016

    Report

    Report Number
    2125050-2016-00227
    Event Type
    Injury
    Date Received
    September 27, 2016
    Report Date
    September 27, 2016
    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.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT'S LEGAL REPRESENTATIVE STATED RECURRENT RECTOCELE WITH SUI, HEMATURIA, SUI, RECURRING UTIS WITH URINARY HESITANCY, DYSURIA WITH URGENCY AND FREQUENCY, URINARY RETENTION WITH SUI, RECURRENT UTIS WITH DYSURIA, FREQUENCY, NOCTURIA, SUPRAPUBIC PAIN AND URGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632940 RESTORELLE DIRECTFIX POS SURGICAL MESH FTL COLOPLAST A/S 5014601400

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other