BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3002356 · Received March 13, 2013

    Report

    Report Number
    2210968-2013-02414
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    IT WAS REPORTED THAT ON (B)(6) 2012, ON EXAMINATION, THE PATIENT HAD [2 X1] CENTIMETER MIDLINE ANTERIOR WALL EROSION AND THE FREE PROTRUDING PART OF MESH WAS EXCISED. ON (B)(6) 2012, EXCISED VAGINAL MESH/FOREIGN BODY ,FROM THE PATIENT, CONSISTING OF ONE SYNTHETIC MESH IN FORMALIN, MEASURING 7 X .4 X .1.CENTIMETERS WAS RECEIVED BY A REFERENCE LABORATORY. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, FISTULAE, BLEEDING, RECURRENCE, DYSPAREUNIA, AND OTHER OUTCOMES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EXTRUSION AND UNDERWENT ¿MESH TRIMMING¿ IN 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, URGENCY, ATROPHIC VAGINITIS, AND VAGINAL ITCHING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. 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
    104849 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC. NA 3099043

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention