BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGEN SLING

    MDR report key: 3032820 · Received April 3, 2013

    Report

    Report Number
    3005099803-2013-02045
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER, 407035 COULD NOT BE MATCHED TO THE UPN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROTEGEN SLING WAS IMPLANTED ON (B)(6) 1998. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN, VAGINAL DISCHARGE, MESH EROSION, INFECTIONS AND AN ADDITIONAL PROCEDURE FOR THE REMOVAL OF THE MESH. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137062 PROTEGEN SLING MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER M0068201210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention