BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 2883891 · Received December 21, 2012

    Report

    Report Number
    3005099803-2012-06179
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6), 2008.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS.ACCORDING TO THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED IN (B)(6) OF 2008 DUE TO IRRITATION REPORTED BY THE PATIENT.ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFYX PPS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER UNK335

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention