BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 6277590 · Received January 25, 2017

    Report

    Report Number
    1018233-2012-02002
    Event Type
    Other
    Date Received
    January 25, 2017
    Report Date
    January 9, 2017
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL/PERIANAL/PERITONEAL PAIN, PAIN WORSENING WITH STANDING/WALKING/INTERCOURSE, DYSPAREUNIA, PELVIC PAIN, MESH EROSION, VAGINAL TENDERNESS TO PALPATION, SUTURES ERODED INTO BLADDER (FOREIGN BODY IN PATIENT), VAGINOTOMY/CYSTOTOMY (ORGAN PERFORATION), VAGINAL DEFECT, BLOOD LOSS, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Description of Event or Problem · 0

    PER ADDITIONAL INFO RECEIVED, THE PATIENT HAS EXPERIENCED SHARP DYSPAREUNIA, "FEELS LIKE RIPPING AND TEARING ANYTIME I TRY TO WALK OR SIT"/"PAIN UNDER MY BUTTOCKS AND WHAT FEELS LIKE RIPPING AND SHARP PAIN, WHERE MY LEGS MEET THE BUTTOCKS," INABILITY TO SIT IN A CHAIR WITHOUT PAIN OR SIT LIP AT A KEYBOARD PROPERLY AT WORK, WITH SUBSEQUENT CARPEL TUNNEL SYMPTOMS (PAIN IN WRISTS, FOREARMS, SHOULDERS, NECK) AFTER USING A LAPTOP WHILE SITTING ON A SOFA, SORENESS OF THE LOWER ABDOMEN TO TOUCH, SWELLING WITH WEIGHT GAIN BECAUSE OF INABILITY TO EXERCISE, PROTRUDING ABDOMEN, SORENESS ON HIPS AND STOMACH, STOMACH MUSCLES TENSING/CRAMPING UP FROM THE PAIN, URINARY TRACT INFECTIONS/RECURRENT OR CHRONIC VAGINAL OR BLADDER INFECTIONS, BLADDER STRESS INCONTINENCE, RECTOCELE, "VAGINAL, PERINEAL, AND PERIANAL PAIN WITH STANDING, WALKING, AND SITTING EVER SINCE THE SURGERY," RECTAL PAIN, URGE-INCONTINENCE, MINIMAL RECURRENT ANTERIOR VAGINAL WALL PROLAPSE, "MESH PUNCTURE THROUGH BLADDER AND VAGINAL," "VAGINAL MESH AND SUTURE REMOVAL DENSE FIBROUS CONNECTIVE TISSUE WITH CHRONIC INFLAMMATION AND FOREIGN BODY GIANT CELL REACTION TO SYNTHETIC MESH / SUTURE MATERIAL" ((B)(6) 2012 PATHOLOGY DIAGNOSIS), CATHETER WITH URINE BAG FOR TWO WEEKS AFTER MESH REMOVAL SURGERY WHICH WAS VERY PAINFUL, BOWEL PERFORATION, BOWEL OBSTRUCTION, CHRONIC CONSTIPATION, UNSPECIFIED PELVIC TRAUMA, FEELING OF THE TENDONS ON LEGS PULLING AND CRAMPING, "A RED MARK ON THE OUTSIDE OF MY BUTTOCKS WHERE THE MESH HAD BEEN RUBBING UP AGAINST MY SKIN AND IT FELT LIKE POKING THROUGH FROM THE INSIDE"(NEAR INCISION SITE; OCCURRED AFTER WALKING WHILE WEARING SPANX), "PAIN THAT COMES WHEN STOMACH IS FULL OR BOWEL MOVEMENTS ARE HARD," "PAIN FROM NERVE DAMAGE AFTER LIVING WITH THE PAIN FOR TWO YEARS," EMOTIONAL AND MENTAL STRESS, "FEELING DEPRESSED...MENTALLY NOT AS SHARP AS I USED TO BE," FAMILY STRESS, VAGINAL TRIGGER INJECTIONS WITHOUT IMPROVEMENT ((B)(6) 2012), TENDER ANTERIOR AND APICAL MESH/MESH-RELATED VAGINAL AND PELVIC PAIN, "(B)(6) DID STATE THAT THERE WAS MESH ATTACHED TO MY SPINE, TAILBONE AREA THAT HE CHOSE "NOT REMOVE" FOR FEAR THAT IT COULD DAMAGE MY SPINE," "I AM NO LONGER ABLE TO WEAR JEANS OR ANY CLOTHING THAT WOULD BE TIGHT FITTING," CONTINUED PAIN AFTER MESH REMOVAL, "CANNOT SIT IN A CAR, CHAIR, AND ESPECIALLY NOT BLEACHERS WITHOUT PAIN AND HAS TO TAKE A GEL SEAT CUSHION EVERYWHERE SHE GOES," "I HAVE TO TAKE MIRALAX AND PAIN MEDICINE EVERY DAY AND FEEL LIKE THESE SURGERIES HAVE AGED ME 10 YEARS OR MORE," APPENDIX RUPTURE (2012), "IN MANY WAYS I FEEL LIKE I HAVE BEEN CASTRATED AND MUTILATED BECAUSE I CANNOT HAVE SEX OR EVEN MASTURBATE COMFORTABLY, AND AM UNCOMFORTABLE EVEN DATING FOR FEAR OF EXPLAINING THIS SITUATION"/"AFRAID TO DATE AND ESPECIALLY HAVE SEX BECAUSE...BECAUSE THE SITUATION IS A LOT TO EXPLAIN TO A NEW PERSON," "I DON'T FEEL LIKE I WILL EVER BE NORMAL AGAIN," "I AM ALWAYS IN PAIN, AND THIS HAS BEEN STRESSFUL ON MY KIDS," AND "I LIVE IN FEAR OF LOSING MY JOB AND NOT BEING ABLE TO TAKE CARE OF MY KIDS." THE PATIENT UNDERWENT MESH REMOVAL (EXPLORATORY LAPAROTOMY REVISION/REMOVAL OF PROSTHETIC VAGINAL GRAFT OPEN ABDOMINAL APPROACH; (B)(6) 2012).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61279 PELVITEX POLYPROPYLENE MESH FTL SOFRADIM PRODUCTION NA PJC00435

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention AJUST ADJUSTABLE SINGLE-INCISION SLING