BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3232507 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13556
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    August 16, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO POP; CONCURRENT PROCEDURES- ANTERIOR COLPORRHAPHY, PARAVAGINAL REPAIR, ILIOCOCCYGEAL VAULT SUSPENSION WITH MESH, TOTAL VAGINAL HYSTERECTOMY AND CYSTOSCOPY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, URINARY PROBLEMS, RECURRENCE, INFECTION, BOWEL PROBLEMS AND BLEEDING. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL MESH AND CYSTOSCOPY ON (B)(6) 2012 DUE TO VAGINAL MESH EROSION AND RECURRENT VAGINAL VAULT PROLAPSE. (B)(4).

    Additional Manufacturer Narrative · 1

    .

    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

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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
    334879 GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3511352

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention