BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3303119 · Received August 22, 2013

    Report

    Report Number
    2210968-2013-19773
    Event Type
    Death
    Date Received
    August 22, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT POSTERIOR REPAIR AND BILATERAL SACROSPINOUS FIXATION DUE TO SYMPTOMATIC RECTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING AND NERVE DAMAGE. (B)(4).

    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

    DATE SENT TO THE FDA: 09/23/2013, 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). THIS EVENT IS REPORTABLE AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    407150 GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3205554

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention