BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3190305 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11186
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 02/08/2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT BURCH RETROPUBIC URETHROPEXY, PARAVAGINAL DEFECT REPAIR, TAH/BSO, ABDOMINAL SACRAL COLPOPEXY, AND CYSTOSCOPY DUE TO SYMPTOMATIC POP ON CARE PROTOCOL.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON 6/30/04 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, EXCISION OF PREVIOUSLY PLACED SACROCOLPOPEXY MESH, URETHROLYSIS AND REMOVAL OF PARAVAGINAL SUTURES, CYSTOTOMY AND REPAIR, CYSTOURETHROSCOPY, BILATERAL URETERAL STENT PLACEMENT, POSTERIOR COLPORRHAPHY ON (B)(6) 2006, DUE TO CHRONIC PELVIC PAIN, VOIDING DYSFUNCTION, PELVIC ORGAN PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY & BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING.

    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

    DATE SENT TO THE FDA: 09/05/2013. 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) 2004 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
    289595 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK TDE903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention