BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2880131 · Received December 19, 2012

    Report

    Report Number
    2210968-2012-08312
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A CYSTOCELE, A RECTOCELE, A BILATERAL PARAVAGINAL DEFECT, AND MIXED URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PELVIC PAIN, EROSION, URINARY PROBLEMS, RECURRENCE OF PROLAPSE, DYSPAREUNIA, VAGINAL SCARRING AND INFECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2011 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) - URINARY PROBLEMS; RECURRENT PROLAPSE; DYSPAREUNIA.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-08313. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention