BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2801625 · Received October 23, 2012

    Report

    Report Number
    2210968-2012-06820
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT PATIENT HAS PAIN, BLEEDING, UTIS, SCARRING, ATROPHY, ADHESIONS AND INCONTINENCE.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT RECURRENT STAGE II VAGINAL VAULT PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SEVERE INCONTINENCE, URGENCY, FREQUENCY, NOCTURIA, RECURRENT CONSTIPATION, RECURRENT URINARY TRACT INFECTIONS, SEVERE VAGINAL IRRITATION, VAGINAL DRYNESS, URINARY OBSTRUCTION, ANTERIOR AND POSTERIOR GRANULATION TISSUE, VAGINAL SCARRING, ABDOMINAL AND PELVIC PAIN, VAGINAL ATROPHY, VAGINAL BLEEDING, INCOMPLETE BLADDER EMPTYING, AND ADHESIONS OF SMALL BOWEL TO VAGINAL CUFF. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06817. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS NOT SPECIFIED WHICH DATE THE MESH WAS IMPLANTED ON. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. THE PATIENT 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
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA CEB889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention