BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 3143005 · Received May 30, 2013

    Report

    Report Number
    2183959-2013-00841
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    January 1, 2010
    Report Date
    May 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. LAWYER-FILED REPORT - (B)(4).

    Description of Event or Problem · 1

    RELATED TO MFR REPORT NUMBER: 2183959-2013-00842. IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A MONARC SUBFASCIAL HAMMOCK IN (B)(6) 2010 FOR THE TREATMENT OF HER PELVIC ORGAN PROLAPSE (POP) AND STRESS URINARY INCONTINENCE (SUI) SYMPTOMS. FOLLOWING THE SURGERY, THE PLAINTIFF SUFFERED A PULMONARY EMBOLISM. SHE BEGAN TAKING WARFARIN TO AVOID FUTURE CLOTS. THE PLAINTIFF SUFFERED POP AND SUI AGAIN IN 2012 AND COULD FEEL HER BLADDER PROTRUDING OUTSIDE OF HER VAGINAL OPENING. IN ADDITION TO THE CYSTOCELE AND RECTOCELE, THE SURGEON IDENTIFIED A GRADE 1 DISTAL VAULT PROLAPSE. ON (B)(6) 2012 THE PLAINTIFF UNDERWENT SURGERY TO EXCISE THE MESH. SHE HAD A 3MM VAGINAL EROSION WITH EXPOSURE OF THE UNDERLYING MESH IN THE MIDPORTION OF THE VAGINAL WALL JUST TO THE LEFT OF THE MIDLINE. SHE HAD AN ANTERIOR VAGINAL WALL DISSECTION AND DISSECTION OF THE PREVIOUS MESH. SHE HAD EXCISION OF THE MESH EXPOSURE AND CLOSURE OF THE VAGINA EPITHELIUM. SHE HAD SUTURES IN THE FRONT AND BACK OF HER VAGINAL OPENING IN ORDER TO HOLD HER PROLAPSED BLADDER IN PLACE WHILE SHE RECOVERED FROM THE SURGERY. ADDITIONALLY, THE PLAINTIFF EXPERIENCED DYSPAREUNIA, FREQUENT BLADDER INFECTIONS, PELVIC PAIN, RECURRENT PROLAPSE, SUI DURING RECURRENT PROLAPSE, PERFORATIONS IN HER VAGINA, SCAR TISSUE AROUND HER BLADDER NECK, EMOTIONAL DISTRESS, MENTAL DISTRESS, ANGER, DEPRESSION AND ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238167 MONARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R| S MONARC IMPLANTED| MONARC IMPLANTED