BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 2870893 · Received December 12, 2012

    Report

    Report Number
    3005099803-2012-06012
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, THE PATIENT WEIGHED (B)(6). ON (B)(6), 2009, SHE WEIGHED (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6), 2009.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS.ALL OTHER INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013: ON (B)(6), 2008, THE PATIENT WAS INVOLVED IN AN ACCIDENT AND SUFFERED AN IMPACT-RELATED PARAVAGINAL TEAR. THE PHYSICIAN PERFORMED A LEFT-SIDED PARAVAGINAL REPAIR WITH PREFYX PREPUBIC SLING PLACEMENT ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT COMPLAINED OF PUBIC BONE PAIN, WHICH WAS TREATED WITH PERCOCET AND ANALGESIC INJECTION. THE PATIENT COMPLAINED OF CALF PAIN ON THE FOLLOWING DAY, BUT AN ULTRASOUND REVEALED NO CLOTS. ON (B)(6) 2008 THE PATIENT INDICATED THAT THE GROIN PAIN PERSISTED, HOWEVER, PREVIOUSLY REPORTED NAUSEA SYMPTOMS HAD IMPROVED. ON (B)(6) 2009, THE PATIENT COMPLAINED OF CRAMPING, URINARY FREQUENCY AND URGENCY. SUBSEQUENT EXAMINATION REVEALED A RESIDUAL RECTOCELE, WHICH WAS TREATED WITH ENABLEX. ON (B)(6) 2009 THE PATIENT WAS IMPLANTED WITH XENFORM TISSUE REPAIR MATRIX. ON (B)(6) 2010, THE PATIENT COMPLAINED OF RIGHT PELVIC PAIN, SPASM, URINARY FREQUENCY AND WAS TREATED WITH SANCTURA. EXAMINATION WAS NORMAL. ON (B)(6) 2010, THE PATIENT PRESENTED WITH PAIN IN THE LEFT RECTUS MUSCLE AND A POSSIBLE HERNIA; A GENERAL SURGEON PERFORMED A REPAIR. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    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 Other