BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3190407 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11216
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    September 20, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT EXAMINATION UNDER ANESTHESIA ON (B)(6) 2011 CONCURRENTLY WITH DILATATION AND CURETTAGE, AND DIAGNOSTIC HYSTEROSCOPY DUE TO POSTMENOPAUSAL BLEEDING WITH TAMOXIFEN. (B)(4).

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

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PELVIC RELAXATION, VAGINAL REPAIR. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL AND HYSTERECTOMY ON (B)(6) 2011 DUE TO MESH EROSION, PELVIC PAIN, AND BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. 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
    291382 GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3296069

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention