BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2781900 · Received October 11, 2012

    Report

    Report Number
    2210968-2012-06424
    Event Type
    Injury
    Date Received
    October 11, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL, PERINEOPLASTY, AND A+P REPAIR ON (B)(6) 2007.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED DUE TO SUI AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, AND VAGINAL SCARRING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS, NOCTURIA, INCONTINENCE, FREQUENCY, URINARY LEAKAGE, INCOMPLETE BLADDER EMPTYING, AND MICROSCOPIC HEMATURIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2002 AND ADDITIONAL MESH AND SLING WERE IMPLANTED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2015-07704 AND 2210968-2015-07701. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS USED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS, NOCTURIA, INCONTINENCE, FREQUENCY, URINARY LEAKAGE, INCOMPLETE BLADDER EMPTYING, AND MICROSCOPIC HEMATURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA UKP345

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention