BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2772197 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-05854
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ URINARY PROBLEMS; UNDEFINED RECURRENCE; DYSPAREUNIA. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE WITH HYPERMOBILITY OF URETHRA. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA. IT WAS REPORTED THAT ON (B)(6) 2010, DUE TO RECURRENT STRESS URINARY INCONTINENCE THE PATIENT UNDERWENT MESH IMPLANTATION. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY WITH HYDRODISTENTION, AND REVISION OF VAGINAL SLING ON (B)(6) 2009 DUE TO PELVIC PAIN, AND EROSION OF SLING.

    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.THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-05852. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND AN UNKNOWN TRANSVAGINAL SURGICAL MESH POLYPROPYLENE DEVICE 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. IT WAS REPORTED THAT ON (B)(6) 2010 MESH WAS IMPLANTED DUE TO RECURRENT STRESS URINARY INCONTINENCE WITH HYPERMOBILITY OF URETHRA. FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY WITH HYDRODISTENTION, AND REVISION OF VAGINAL SLING ON (B)(6) 2009 DUE TO PELVIC PAIN AND EROSION OF SLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND AN UNKNOWN TRANSVAGINAL SURGICAL MESH POLYPROPYLENE DEVICE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL, POLYMERIC FTL ETHICON SARL A JOHNSON & JOHNSON COMPANY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention