BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2760532 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05573
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH ¿PLACATION¿ OF ENTEROCELE ON (B)(6) 2007 DUE TO VAGINAL VAULT PROLAPSE. SHE EXPERIENCED PERSISTENT MESH EROSION, VAGINAL BLEEDING, CRAMPING, GRANULATION, AND URINARY INCONTINENCE. IT IS ALSO REPORTED THAT SPOTTING BEGAN AROUND (B)(6) 2008 ON EXERTION IN PHYSICAL THERAPY, AND THAT ALL ARE ONGOING. IT IS FURTHER REPORTED THAT SHE IS SEEKING PSYCHIATRIC CARE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH PLACATION OF ENTEROCELE, VAGINAL VAULT SUSPENSION, ANTERIOR REPAIR AND CYSTOURETHROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3026838

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention