BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT-O

    MDR report key: 2822639 · Received October 29, 2012

    Report

    Report Number
    MW5027470
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 29, 2012
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2007, I WAS DIAGNOSED WITH URINARY STRESS INCONTINENCE. IT WAS TREATED WITH A TVT-O. TWO TO THREE YRS LATER, INTERCOURSE STARTED TO BECOME PAINFUL, BUT I ATTRIBUTED THAT PAIN TO VAGINAL DRYNESS FROM POST MENOPAUSAL SYNDROME. ABOUT 2 YRS AGO I STARTED EXPERIENCING DEEP RIGHT SIDED GROIN PAIN AS WELL. ABOUT 6 MONTHS AGO MY HUSBAND STATED THAT HE WAS STARTING TO EXPERIENCE PAIN DURING INTERCOURSE AND WAS IN FACT BEING SCRATCHED AND SCARRED FROM THE MESH. I WAS REFERRED TO A UROGYNECOLOGIST. DURING A VAGINAL SCOPE, I WAS ABLE TO SEE THE BRIGHT BLUE MESH THAT HAD TOTALLY ERODED INTO MY VAGINAL CANAL. ON (B)(6) 2012, THE MESH THAT HAD ERODED INTO THE VAGINAL CANAL WAS CUT OUT. IT HAS BEEN SUGGESTED THAT ANY ATTEMPT TO REMOVE THE ENTIRE MESH MIGHT VERY WELL CAUSE MORE GROIN INJURY AND PAIN THAN I EXPERIENCED NOW, ON A DAILY BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVT-O BLADDER STRAP FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R