BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2760434 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05618
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    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

    (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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT THE PATIENT, ON (B)(6) 2008 SHEEP MESH WAS ADDED BECAUSE OF BLEEDING WALLS OF VAGINA TEARING. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH VAGINAL VAULT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PLACEMENT OF ALLODERM MESH AND REAPPROXIMATION OF VAGINAL INCISION ON (B)(6) 2008 DUE TO VAGINAL WOUND SEPARATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2009 DUE TO VAGINAL MUCOSAL SEPARATION AND SYNTHETIC MESH EXPOSURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND EXPLANT OF ANTERIOR VAGINAL WALL MESH, VAGINAL PARAVAGINAL REPAIR USING SIS BIOLOGIC MESH, CYSTOURETHROSCOPY AND VAGINAL REVISION ON (B)(6) 2009 DUE TO VAGINAL MESH EXPOSURE, VAGINAL SCARRING, AND DYSPAREUNIA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. 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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention