BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2222130 · Received August 24, 2011

    Report

    Report Number
    2210968-2011-01171
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ETHICON INC
    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

    DATE SENT TO THE FDA: (B)(4) 2011.(B)(4): 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). (B)(6). IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED COMPLICATIONS INCLUDING EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. IN 2010, THE PATIENT WAS AGAIN DIAGNOSED WITH A RECTOCELE, AND SHE UNDERWENT A POSTERIOR COLPORRHAPHY IN (B)(6) 2010. 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). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL AND ABDOMINAL PAIN, PELVIC PAIN, SCAR TISSUE FORMATION, ANEMIA, VAGINAL BLEEDING, URINARY TRACT INFECTIONS, DYSPAREUNIA, BLEEDING, PAIN DURING SEXUAL INTERCOURSE, ANXIETY, DEPRESSION, INCREASED INCONTINENCE, BLADDER PROLAPSE, AND THE NEED FOR MULTIPLE PROCEDURES, TESTS, MEDICATIONS AND MEDICAL INTERVENTION. (B)(4) -RECURRENT PROLAPSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED COMPLICATIONS INCLUDING EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL POLYMERIC FTL ETHICON INC NA 3242278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention