BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2892673 · Received January 2, 2013

    Report

    Report Number
    2210968-2013-00056
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT AN UTEROVAGINAL PROLAPSE, A CYSTOCELE AND A RECTOCELE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A BILATERAL PARAVAGINAL DEFECT REPAIR WITH MESH, A BILATERAL SACROSPINOUS LIGAMENT FIXATION WITH MESH, A RECTOCELE REPAIR WITH MESH AND CYSTOSCOPY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, FISTULAE, BLEEDING PROBLEMS, DYSPAREUNIA, SUTURE PROTRUSION THROUGH RECTAL WALL, MESH IN RECTUM, STOOL LEAKAGE PER VAGINA, FOUL ODOR, RECTAL HOLE, CRAMPS AND NECROTIC TISSUE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ERODED MESH FROM VAGINA AND RECTUM ON (B)(6) 2011 DUE TO MESH EROSION INTO VAGINA AND RECTUM. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL, REPAIR OF RECTOVAGINAL FISTULA USING SURGISIS, AND PROTOSCOPY ON (B)(6) DUE TO FECAL MATTER AND DISCHARGE FROM VAGINA, MESH EROSION INTO THE RECTUM AND THE VAGINA, AND A RECTOVAGINAL FISTULA ASSOCIATED WITH MESH EROSION. (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3270158

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention