BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2970151 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01317
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT POST HYSTERECTOMY VAGINAL VAULT PROLAPSE, CYSTOCELE, ENTEROCELE, RECTOCELE, URINARY RETENTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF SUPRAPUBIC CATHETER PLACEMENT, HIGH UTEROSACRAL LIGAMENT VAGINAL VAULT SUSPENSION AND ENTEROCELE PLACATION. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF TWO SUTURES FROM VAGINA, ABDOMINAL COLPOPEXY, AND BURCH RETROPUBIC URETHROPEXY ON (B)(6) 2010 DUE TO RECURRENT PELVIC ORGAN PROLAPSE WITH ENTEROCELE AND STRESS URINARY INCONTINENCE. PATIENT ALSO UNDERWENT EXCISION OF VAGINAL DYSPLASIA AND REMOVAL OF PERMANENT VAGINAL SUTURE WITH VAGINAL MESH ON 05/07/2012 DUE TO VAGINAL FOREIGN BODY AND VAGINAL INTRAEPITHELIAL NEOPLASIA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73646 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA XPB458

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention