BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 2132671 · Received June 17, 2011

    Report

    Report Number
    3005099803-2011-02163
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS EVENT IS ADDITIONAL INFORMATION FOR THE SAME PATIENT AND PROCEDURE REPORTED IN MDR 6000043-2006-00006. THE PATIENT REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROTEGEN VESICA SLING WAS USED DURING A PROCEDURE IN SEPTEMBER, 1998. THE PATIENT REPORTS THAT SHE IS HAVING CONTINUES PROBLEMS. THE DETAILS OF THE "PROBLEMS" ARE UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other