BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3181060 · Received June 20, 2013

    Report

    Report Number
    2210968-2013-10687
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    August 12, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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). REASON FOR SURGERY: SUI, CYSTOCELE . CONCURRENT PROCEDURES: PERIVAGINAL DEFECT REPAIR, CYSTOCELE REPAIR. IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, INFECTION, AND BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION WITH REVISION OF CYSTOCELE ON (B)(6) 2006 DUE TO EXTRUSION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2006 DUE TO EXTRUDED MESH BY (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 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
    280873 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 1396900

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention