BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 3191360 · Received June 26, 2013

    Report

    Report Number
    3005099803-2013-05323
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PRE-PUBIC SLING SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT PRESENTED WITH VAGINAL PAIN AND DISCOMFORT ON (B)(6) 2011 AND WITH PELVIC PAIN ON (B)(6) 2011. THE PATIENT HAS NOT BEEN SEEN SINCE. ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291242 PREFYX PPS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER UNK335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other