BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3023928 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02700
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-02701. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT CYSTOCELE AND PELVIC ORGAN PROLAPSED AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED CHRONIC PELVIC PAIN, VAGINAL AREA PAIN, URINARY INCONTINENCE, BLADDER PROLAPSE, URETHRAL PAIN, URINARY INFECTIONS, URINARY BURNING AND URINARY RETENTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS DUE TO CHRONIC PAIN THAT CAUSED TERRIBLE REACTIONS. THE MESH EROSION REQUIRED 3 ADDITIONAL SURGERIES AND CAUSED PHYSICAL PAIN AND DISCOMFORT DOING REGULAR ACTIVITIES; ANXIETY AND A DECREASE OVERALL OF QUALITY OF LIFE ALONG WITH UNRELENTING PAIN, SEVERE INJURIES RELATED TO THE DEVICE AND EMBARRASSMENT TO GO OUT IN PUBLIC DUE TO THE INABILITY TO CONTROL THE BLADDER. THE PATIENT ALSO UNDERWENT ANTERIOR COMPARTMENT REPAIR WITH MESH ON (B)(6) 2008 AND AUTOLOGOUS PUBOVAGINAL SLING /URETEROLYSIS ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2001 AND (B)(6) 2008 AND MESH WAS IMPLANTED. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126200 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention