BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3040930 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03589
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 19, 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): IT WAS REPORTED THAT THE PATIENT UNDERWENT SACROCOLPOPEXY MESH REVISION, RECTOCELE REPAIR, ENTEROCELE REPAIR, HIGH UTEROSACRAL VAULT SUSPENSION, PLACEMENT OF 4 X 7 FASCIA LATA GRAFT AND RECTOCELE REPAIR ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PROCIDENTIA, CYSTOCELE, AND OCCULT URINARY INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF SUPRACERVICAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, ABDOMINAL SACRAL COLPOPEXY, PARAVAGINAL DEFECT REPAIR AND BURCH RETROPUBIC URETHROPEXY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, URINARY/BOWEL PROBLEMS, AND RECURRENCE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 DUE TO EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) ¿ URINARY/BOWEL PROBLEMS; UNDEFINED RECURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2004 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143227 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA TAB258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention