BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3141336 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06347
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 14, 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

    (B)(4). 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2004 IN ORDER TO TREAT A LARGE PULSION ENTEROCELE APPROXIMATELY 6CM BEYOND THE INTROITUS AND STRESS URINARY INCONTINENCE CONCURRENTLY WITH A LAPAROSCOPIC SACROCOLPEXY WITH BURCH PARAVAGINAL REPAIR AND CYSTOSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    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). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, AND URINARY FREQUENCY. IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC SACRAL COLPOPEXY WITH DAVINCI ON (B)(4) 2008 BY DR. (B)(6) DUE TO TOTAL VAGINAL PROLAPSE AT (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROSCOPY WITH EXTENSIVE ADHESIOLYSIS, LAPAROSCOPIC EXCISION OF VAGINAL MESH, LAPAROSCOPIC SACRAL COLPOPEXY WITH LAPAROSCOPIC REPAIR OF ANTERIOR AND POSTERIOR VAGINAL WALL, AND CYSTOURETHROSCOPY ON (B)(6) 2017 BY DR. (B)(6) DUE TO RECURRENCE OF PROLAPSE AT (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE ON (B)(6) 2004 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, AND URINARY FREQUENCY. IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC SACRAL COLPOPEXY WITH DAVINCI ON (B)(6) 2008 BY DR. (B)(6) DUE TO TOTAL VAGINAL PROLAPSE AT (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROSCOPY WITH EXTENSIVE ADHESIOLYSIS, LAPAROSCOPIC EXCISION OF VAGINAL MESH, LAPAROSCOPIC SACRAL COLPOPEXY WITH LAPAROSCOPIC REPAIR OF ANTERIOR AND POSTERIOR VAGINAL WALL, AND CYSTOURETHROSCOPY ON (B)(6) 2017 BY DR. (B)(6) DUE TO RECURRENCE OF PROLAPSE AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245109 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA SPE685

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention