BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3162805 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10118
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ DYSPAREUNIA; LEAKAGE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL SURGERY ON (B)(6) 2005 AND MESH WERE PLACED INTO THE PATIENT¿S BODY. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. FOLLOWING INSERTION THE PATIENT EXPERIENCED WORSENING URINARY INCONTINENCE, VAGINAL PAIN, PELVIC PAIN, PAIN DURING SEXUAL INTERCOURSE, PAIN WHEN SITTING , STANDING WITH AND WITH MOVEMENT, VAGINAL SCARRING, LEAKAGE, LOST CONFIDENCE, SEVERE EMBARRASSMENT, FEELS DAMAGED AS A WOMAN, INTERCOURSE DIFFICULT AND PAINFUL AND THREE MESH REVISION SURGERIES. THE PATIENT ALSO EXPERIENCED WORSENING STRESS INCONTINENCE, CHRONIC VAGINAL PAIN, AND BLEEDING. SHE UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2010 BY FOR URINARY INCONTINENCE AND RECTOCELE. THE PATIENT UNDERWENT TWO ADDITIONAL SURGERIES AND UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262321 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention