BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2830572 · Received November 13, 2012

    Report

    Report Number
    2210968-2012-07286
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT RECTAL PERINEOCELE, PERONEAL DESCENT, CYSTOURETHROCELE, VAGINAL VAULT PROLAPSE, ANAL SKIN TAG, POOR COSMETIC RESULT AFTER LOW TRANSVERSE SCAR AND CHRONIC TONSILLITIS. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF SCAR REVISION, ANAL SKIN TAG REMOVAL, TONSILLECTOMY, ABDOMINAL SACRAL COLOPEXY AND POSTERIOR COLPORRHAPHY PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2010 IN ORDER TO TREAT WEAK RECTOVAGINAL TISSUE, CYSTOCELE, AND STAGE TWO RECTOCELE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT POST INSERTION PATIENT EXPERIENCED PAIN, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND URINARY/BOWEL PROBLEMS. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT 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
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA CJB201

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention