BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3113360 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05556
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A MESH IMPLANTATION PROCEDURE ON (B)(6) 2003 TO TREAT URINARY INCONTINENCE AND VAGINAL VAULT PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, BLEEDING, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, CAUSED LACERATIONS TO SPOUSE AND VAGINAL SCARRING. THE PATIENT UNDERWENT MESH REVISION PROCEDURES ON (B)(6) 2004, (B)(6) 2004, AND (B)(6) 2005. IT WAS REPORTED THAT THE PATIENT HAD INTERSTIM IMPLANTED ON (B)(6) 2010 DUE TO RECURRENCE. IT WAS REPORTED THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE AND HAD COLOPLAST TUTOPLAST IMPLANTED ON (B)(6) 2011. THE PATIENT EXPERIENCED EROSION AND UNDERWENT REMOVAL PROCEDURES ON (B)(6) 2011 AND (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT PUBOVAGINAL SLING WITH AUTOLOGOUS RECTUS FASCIA, SUPRAPUBIC CATHETER INSERTION, PARTIAL REMOVAL OF MESH IMPLANT AND PARTIAL EXCISION OF VAGINAL WALL WITH IRRIGATION AND DEBRIDEMENT WITH COMPLEX VAGINAL WALL CLOSURE ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05551. 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) 2003 AND MESH WAS IMPLANTED. 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
    215258 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA SAE424

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention