BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2103081 · Received May 25, 2011

    Report

    Report Number
    2210968-2011-00676
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT A PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE ON (B)(6) 2009 AND CONCURRENTLY HAD A SUPRACERVICAL HYSTERECTOMY AND REMOVAL OF FALLOPIAN TUBES, PERFORMED A DIFFERENT PHYSICIAN. THE PATIENT EXPERIENCED VAGINAL PAIN, PELVIC PAIN, INABILITY TO SIT, STAND OR WALK FOR LONG PERIODS OF TIME, DYSPAREUNIA, BURSITIS IN HIPS, ANXIETY, DEPRESSION, AND THE NEED FOR MULTIPLE PROCEDURES, TESTS, MEDICATIONS. ON (B)(6) 2010, PART OF THE ANTERIOR MESH WAS REMOVED. ON (B)(6) 2010, MORE OF THE ANTERIOR MESH WAS REMOVED. ON (B)(6) 2011, SIGNIFICANT REMNANTS OF BOTH THE ANTERIOR AND POSTERIOR INCLUDING THE ARMS WERE REMOVED. (B)(4) BURSITIS IN HIPS. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-00384. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, PELVIC FLOOR REPAIR MESH WAS IMPLANTED. THE PATIENT EXPERIENCED EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON NA 3270160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention