BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3163412 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10180
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO UTEROVAGINAL PROLAPSE AND SUI; CONCURRENT PROCEDURE-HYSTERECTOMY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY/BOWEL PROBLEMS, AND BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT AN UNDERMINING OF VAGINAL MUCOSA WITH EXCISION OF MESH AND CLOSURE OF THE VAGINAL MUCOSA ON (B)(6) 2007 DUE TO EROSION. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT # 2210968-2013-10180 IS BEING VOIDED AS IT IS A DUPLICATE OF MEDWATCH REPORT # 2210968-2013-07286. PLEASE SEE MEDWATCH REPORT # 2210968-2013-07286 FOR ALL INFORMATION REGARDING THIS EVENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WERE 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
    264185 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3021546

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention