BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2800442 · Received October 22, 2012

    Report

    Report Number
    2210968-2012-06775
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (B)(4). 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

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

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH COLONOSCOPY; DUE TO VAGINAL PROLAPSE, MESH EROSION, AND VAGINAL BLEEDING. IT WAS REPORTED THAT THE PATIENT HAD ANTERIOR VAGINAL MESH PLACEMENT (IN 2011), CYSTOSCOPY ((B)(6) 2012), AND HAD RIGHT MANDIBULAR ADENECTOMY ((B)(6) 2013).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT CYSTOCELE AND ENTEROCELE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT POST IMPLANTATION, THE PATIENT EXPERIENCED PAIN AND BLEEDING. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT EXCISION OF ERODED MESH ON (B)(6) 2012 AND MESH REVISION ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 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 3518880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention