BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2771928 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-05976
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A HYDROSALPINX, A CYSTOCELE, AND A RECTOCELE WITH STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY AND ANTERIOR/POSTERIOR REPAIR WITH HER GRAFT DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-05975. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCOMFORT. IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT LAPAROSCOPIC BILATERAL SALPINGO OOPHORECTOMY, ANTERIOR AND POSTERIOR REPAIR. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF VAGINAL MESH WITH POSTERIOR COLPORRHAPHY ON (B)(6) 2013 BY (B)(6) AT (B)(6) DUE TO VAGINAL MESH EXPOSURE AND RECTOCELE.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REMOVAL SURGERY ON (B)(6) 2006 DUE TO POSTERIOR VAGINAL WALL EROSION. SHE HAD AN EXCISION OF EXPOSED VAGINAL MESH AGAIN ON (B)(6) 2011. (B)(4). 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). DYSPAREUNIA. 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. SEE ALSO MEDWATCH 2210968-2012-05975. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCOMFORT. IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT LAPAROSCOPIC BILATERAL SALPINGO OOPHORECTOMY, ANTERIOR AND POSTERIOR REPAIR. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF VAGINAL MESH WITH POSTERIOR COLPORRHAPHY ON (B)(6) 2013 BY (B)(6) AT (B)(6) DUE TO VAGINAL MESH EXPOSURE AND RECTOCELE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2005 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING MESH CONTRACTION, PAIN, EROSION, FORMATION OF SCAR TISSUE, INFECTION, ORGAN PERFORATION, FISTULA, DYSPAREUNIA, NERVE DAMAGE, CHRONIC PELVIC PAIN, URINARY & FECAL INCONTINENCE, AND RECURRENT PROLAPSE OF HER ORGANS REQUIRING ADDITIONAL SURGERIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UKP345

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention