BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAH BSO MONARCH SLING

    MDR report key: 3880271 · Received June 13, 2014

    Report

    Report Number
    MW5036643
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, I WAS HOSPITALIZED AT (B)(6) FOR SURGERY DUE TO BLADDER PROLAPSE. I ALSO HAD A TOTAL HYSTERECTOMY. I WAS TOLD BY MY DOCTOR (B)(6) THAT I WOULD BE FEELING BETTER IN NO TIME. MY FIRST SHOCKER WAS PAINFUL SEX WITH MY NOW EX-HUSBAND. WHEN I TRIED TO GET BACK TO MY ACTIVE LIFESTYLE, WORKING OUT AND EXERCISE, I EXPERIENCE SEVERE PELVIC PAIN. I HAVE FREQUENCY INFECTIONS, CHRONIC PELVIC PAIN, DEPRESSION FROM WEIGHT GAIN AND ALL AROUND LOST IN THE QUALITY OF MY LIFE. I AM CONSTANTLY IN PAIN WHETHER I AM SITTING, STANDING OR LAYING DOWN. MY HEALTH IS GOING DOWNHILL SINCE THE SURGERY AND IMPLANT DEVICE. I CALLED MY DR TO REQUEST IT BE REMOVED AND THEY WOULD NOT DO IT; FEARING IT WOULD CAUSE WORST DAMAGE. I AM DEVASTATED AND ALONE AT (B)(6) OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349939 TAH BSO MONARCH SLING SURGICAL MESH OTN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S