BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2945606 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00872
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00873. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A TRANSVAGINAL HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT BILATERAL ABDOMINAL EXPLORATION WITH URETEROLYSIS, FLUOROSCOPY, CYSTOSCOPY WITH BILATERAL STENT PLACEMENT AND REVISION OF URETEROSACRAL GRAFT AND STENT PLACEMENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY BURNING, URINARY FREQUENCY, INCONTINENCE, URINARY TRACT INFECTION AND INCOMPLETE EMPTYING OF BLADDER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF EXPLORATORY LAPAROTOMY, A HYSTERECTOMY, AND REVISION OF UTEROSACRAL GRAFT DUE TO BILATERAL URETAL OBSTRUCTION AND EXTRAVASTION DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN AND URINARY PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF URETHRAL SUTURE, CYSTOSCOPY, URETOLYSIS, AND BILATERAL STENT IMPLANTATION ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY BURNING, URINARY FREQUENCY, INCONTINENCE, URINARY TRACT INFECTION AND INCOMPLETE EMPTYING OF BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50990 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA BKP214

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention