BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2832100 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07354
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAGINAL PROLAPSE AND A SYMPTOMATIC RECTOCELE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF BILATERAL SACROSPINOUS FIXATION (POSTERIOR) WITH POSTERIOR COLPORRHAPHY DURING MESH IMPLANTATION ON (B)(6) 2007. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-10724. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2007 FOR RECTOCELE REPAIR AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION EXTRUSION, BLEEDING VAGINAL SCARRING AND DYSPAREUNIA. THE PATIENT HAD RECTOCELE REPAIR FOR EROSION OF VAGINAL MESH AND REVISION OF COLPORRHAPHY ON (B)(6) 2007 AND (B)(6) 2008, AND ON (B)(6) 2008 AND (B)(6) 2010, SHE ALSO HAD SURGERY FOR RECTOCELE AND MESH REMOVAL DUE TO EROSION OF MESH INTO VAGINAL WALL. (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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2928844

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention