BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2760488 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05581
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 4, 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, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 2210968-2012-05580. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT DUE TO EROSION, PAIN, INFECTION, DYSPAREUNIA AND VAGINAL SHORTENING, THE MESH WAS EXCISED ON (B)(6) 2012. (B)(4). DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARA VAGINAL REPAIR, PUBI VAGINAL SLING REPAIR, CYSTOSCOPY ON (B)(6) 2004 TO TREAT ENTEROCELE, MIXED URINARY INCONTINENCE, INTRINSIC SPHINCTER, DEFICIENCY URETHRAL MASS AND AN OBTURATOR SLING WAS IMPLANTED. CURRENT STATUS REPORTED ON (B)(6) 2012 INDICATES HEMATURIA, CYSTOSCOPY NORMAL. THE PATIENT HAD KIDNEY STONE/HYDRONEPHROSIS ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, URINARY TRACT INFECTIONS 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 FTL ETHICON, INC. NA TDB850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention