BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK IVS TUNNELLER DEVICE

    MDR report key: 2953853 · Received January 31, 2013

    Report

    Report Number
    6000141-2013-00014
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    April 22, 2005
    Report Date
    January 7, 2013
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT HAS COMPLAINED OF VAGINAL PRESSURE AND/OR PAIN, VAGINAL BLEEDING, DYSPAREUNIA, AND/OR INCONTINENCE.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,THE PATIENT CONTINUES TO HAVE COMPLICATIONS SUCH AS VAGINAL SPOTTING, PINKISH VAGINAL DISCHARGE, URINARY TRACT INFECTION, ATROPHIC VAGINA, SORE HIP, AND ON EXAMINATION, SHE HAD A SMALL DRAINING ULCER ABOUT 4-5 CM LATERAL TO RECTUM ON LEFT BUTTOCK, RECTOCUTANEOUS FISTULA, RECURRENCE OF THE SINUS TRACT AND OCCASIONAL DRAINAGE OF THICK MUCOUS MATERIAL AND RECURRENT INDURATION ON LEFT BUTTOCK, PERIANAL ABSCESS SECONDARY TO PROLENE MESH DURING THE TIME PERIOD (B)(6) 2006-(B)(6) 2010 FOR WHICH SHE WAS TREATED WITH MEDICATIONS AND UNDERWENT THE FOLLOWING SURGERIES, FIRST INTERVENTIONAL SURGERY - (B)(6) 2007 - UNDERWENT EXCISION OF CYST LEFT BUTTOCK (2.4 CM), SECOND INTERVENTIONAL SURGERY - (B)(6) 2008 - UNDERWENT EXPLORATION OF THE FISTULA, INJECTION OF METHYLENE BLUE AND ANOSCOPY, VAGINOSCOPY AND INSERTION OF FOLEY CATHETER, MESH REVISION SURGERY - (B)(6) 2008 - UNDERWENT REVISION OF THE MESH WITH RETRIEVAL AND EXCISION OF THE TAIL OF THE IVS TUNNELER. FINDINGS: ON THE HYMENAL RING ON THE PATIENT'S LEFT SIDE ABOUT 5 O'CLOCK POSITION IS A SMALL OPENING WHERE DR. (B)(6) COULD SEE THE MESH. YES. AS PER THE AVAILABLE MEDICAL RECORDS, THE PATIENT CONTINUED TO DEVELOP COMPLICATIONS SUCH AS ABSCESS AT GLUTEAL REGION SECONDARY TO MESH REJECTION, STILL WITH REDDISH VAGINAL DISCHARGE, EXPOSED PROLENE TAPE AT POSTEROLATERAL VAGINAL WALL ON (B)(6) 2009, RIGHT PERINEAL ABSCESS SECONDARY TO REJECTION OF PROLENE TAPE (IVS TUNNELER), LARGE RIGHT SIDED ISCHIORECTAL ABSCESS, CUTANEOUS VAGINAL FISTULA, RECURRENT FISTULA, PERIVAGINAL ABSCESS RIGHT SIDE ALONG IVS TAPE , ABSCESS OF VULVA, RECURRENT ABSCESS PERIRECTAL SPACE SECONDARY TO IVS TAPE AND MESH EROSION WAS NOTED DURING THE TIME PERIOD (B)(6) 2008-(B)(6) 2012 FOR WHICH SHE UNDERWENT THE FOLLOWING ADDITIONAL INTERVENTIONAL SURGERIES. INTERVENTIONAL SURGERIES: (B)(6) 2009 - UNDERWENT EXCISION OF THE RIGHT LATERAL WALL AND EXCISION OF THE EXPOSED PROLENE SUTURE, IT IS ABOUT 1 INCH LONG OR SO WITH THE KNOTS ON THEM. ON (B)(6) 2010 - UNDERWENT EXPLORATION OF RIGHT PERINEAL AREA ALL THE WAY UP TO THE ISCHIAL SPINE, VAGINAL CUFF LATERALLY AND MEDIALLY WITH NO SUCCESS IN FINDING THE TAPE. ON (B)(6) 2010 - UNDERWENT EXAMINATION UNDER ANESTHESIA, COLONOSCOPY TO CECUM, INCISION AND DRAINAGE OF RIGHT SIDED ISCHIORECTAL ABSCESS. ON (B)(6) 2010 - UNDERWENT EXPLORATION OF THE RIGHT VAGINAL AND ISCHIORECTAL SPACE, LYSIS OF ADHESIONS, EXCISION OF ADHESIVE BANDS AND THE SINUS TRACT CONNECTED TO THE LATERAL WALL OF THE VAGINA AND THE VAGINAL CUFF, ALL THE WAY TO THE ISCHIAL SPINE. DESPITE MULTIPLE INTERVENTIONAL SURGERIES, PATIENT CONTINUED TO HAVE COMPLICATIONS LIKE VAGINAL DISCHARGE, VAGINAL BLEEDING, RECURRENT ABSCESS FORMATION, URINARY TRACT INFECTIONS AND MESH EROSION DURING THE INTERIM TIME PERIOD (B)(6) 2010-(B)(6) 2012 FOR WHICH SHE HAD TO UNDERGO AN ADDITIONAL MESH REVISION SURGERY FOR INFECTED VAGINAL MESH WITH RECURRENT ISCHIORECTAL ABSCESS FORMATION. ADDITIONAL MESH REVISION SURGERY: (B)(6) 2012 - UNDERWENT VAGINAL EXCISION OF INFECTED MESH AND TRANSVAGINAL ISCHIORECTAL EXPLORATION WITH CLEAN OUT OF CHRONIC ABSCESS. HOWEVER, AS PER THE LAST AVAILABLE MEDICAL RECORD ON (B)(6) 2012, THE PATIENT HAD NO FURTHER DISCHARGE OR BLEEDING AND HAD NO BOWEL OR BLADDER COMPLAINTS. SHE HAS NO SYMPTOMS OF PROLAPSE BUT HER VAGINA WAS ATROPHIC AND WITH SCAR TISSUE. HOWEVER, SHE WAS DOING WELL WITHOUT ANY COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42551 UNK IVS TUNNELLER DEVICE IVS TUNNELLER FTL BALLYMONEY - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other