BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3233914 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13682
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    February 15, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005. IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT A&P REPAIR WITH A MESH PLACEMENT AND AN APPENDECTOMY ON (B)(6) 2010 DUE TO POP.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): 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): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAGINAL VAULT PROLAPSE, CYSTOCELE, RECTOCELE, AND ENTEROCELE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF AP REPAIR AND BILATERAL SACROSPINOUS SUSPENSION PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 2/18/2019. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT DIED ON AN UNKNOWN DATE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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
    333436 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 1338835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention