BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO MESH

    MDR report key: 2801781 · Received October 17, 2012

    Report

    Report Number
    MW5027269
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    December 21, 2011
    Report Date
    October 17, 2012
    Manufacturer
    JOHNSON & JOHNSON USA
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A LAPAROSCOPIC SACRAL RECTO COLOPEXY IN (B)(6) 2011, AFTER IT WAS FOUND I HAD A COLLAPSED PELVIS AND BOWEL FOR OVER 5 YRS. THE COLORECTAL SURGEON PERFORMED THE FOLLOWING: "LAPAROSCOPIC SACRAL RECTO COLPOPEXY. PROCEDURE GA PORTS, THE ANTIN RECTUM WAS DISSECTED IN THE RECTO VAGINAL SEPTUM TO THE LEVEL OF PELVIC FLOOR . A SURGIOPRO MESH WAS SECURED TO THE ANTERIOR RECTAL WALL WITH 2/0 NOVAFIL AND TACKED TO THE SACRAL PREMONITORY USING PRO TACKS. CLOSURE OF THE UMBILICAL SHEATH WITH VICRYL AND MONOCRYL TO SKIN." SINCE (B)(6) 2012, I HAVE HAD SEVERE ABDOMEN PAIN RADIATING INTO MY STOMACH AND SURROUNDING AREAS. FEVERS, INFECTIONS, BURNING IN BOTH VAGINA AND BOWEL, RED TYPE FINGER NAIL SIZE SUBSTANCE IN MY FECES, A FEELING SOMETHING FOREIGN SITTING ON TOP OF MY VAGINA. IRREGULAR BLOOD TESTS TO NAME A FEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO MESH SURGICAL MESH FTL JOHNSON & JOHNSON USA 2656

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization PRO TACKS| VICRYL| 2/0 NOVAFIL| MONOCRYL