BEUDAMED
    FDA Adverse Event Summary report: N

    MONARC SUBFASCIAL HAMMOCK

    MDR report key: 3111736 · Received May 8, 2013

    Report

    Report Number
    MW5030136
    Date Received
    May 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AMS
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008 MESH IMPLANT: MONARC SUBFASCIAL HAMMOCK BLADDER SLING FOR POP REPAIR. GROIN PAIN STARTED IN (B)(6) 2012, WORSENING OVER TIME. SPOTTING BLOOD FROM URETHRA, VAGINA. PAIN IN GROIN, DOWN LEGS, VAGINAL INTERCOURSE PAIN, CONSTANT VAGINAL, BLADDER, URETHRA, PELVIC PAIN. I USED TO RUN UP TO 7 MILES A DAY. NOT ABLE TO RUN OR WALK TRACK FOR EXERCISE. CAUSES MORE PAIN AND BLEEDING FROM VAGINA, URETHRA AND RECTUM. ER VISIT (B)(6) 2013 FOR SPOTTING AND PAIN. SENT TO GYN WHO SAYS IT'S MESH EROSION. HE DOES NOT INSTALL THEM ANY MORE; CAUSES INJURY, THAT I NEED IT REMOVED. SENT TO UROLOGIST WHO ONLY WANTS TO REMOVE ARMS OF IMPLANT, LEAVE THE REST IN. HE ALSO BRAGGED THAT HE STILL INSTALLS SLINGS. CURRENTLY, TRYING TO GET INSURANCE APPROVAL FOR TOTAL REMOVAL FROM EXPERIENCED UROLOGIST WHO SPECIALIZES IN MESH REMOVAL IN (B)(6). PLEASE BAN ALL MESH, THIS IS TORTURE AND I PRAY NO OTHER MAN OR WOMAN RECEIVES THIS HELL. I WILL ALSO HAVE TO HAVE ANOTHER SLING SURGERY AFTER HEALING FROM MESH REMOVAL FOR POP. THERE IS A SLING MADE FROM YOUR OWN FLESH THAT I WILL HAVE MADE AND PUT IN FOR THE SECOND SURGERY. I DO NOT WANT MY IDENTITY DISCLOSED AS I HAVE OBTAINED AN ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200137 MONARC SUBFASCIAL HAMMOCK BLADDER SLING/MESH IMPLANT OTN AMS 72403830 549883005

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R