BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECT FIX POSTERIOR

    MDR report key: 3032539 · Received April 3, 2013

    Report

    Report Number
    2125050-2013-00038
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    April 1, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    INFECTION AND PAIN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137379 RESTORELLE DIRECT FIX POSTERIOR SURGICAL MESH FTL COLOPLAST A/S 5014601400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other