BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3213801 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12658
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    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

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2007 AND (B)(6) 2012.

    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT INCONTINENCE AND CYSTOCELE AND RECTOCELE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF ANTERIOR COLPORRHAPHY AND ENTEROCELE REPAIR PERFORMED DURING MESH IMPLANTATION. IN ADDITION, 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004, AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT I&D OF VAGINAL CYST ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT CORRECTION OF ENTEROCELE, POSTERIOR COLPORRHAPHY AND COLPOPERINEORRHAPHY ON (B)(6) 2013 DUE TO POP, DISRUPTED PERINEAL BODY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE; ANTERIOR COLPORRHAPHY AND ENTEROCELE REPAIR ON (B)(6) 2004 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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
    313981 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK SPF302

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention