BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 3151429 · Received June 7, 2013

    Report

    Report Number
    2210968-2013-06446
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    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). 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 HAS BEEN REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE EXPOSED MESH, REVISION OF THE ARMS OF THE MESH AND CYSTOSCOPY ON (B)(6) 2012 BY DR. (B)(6) DUE TO VAGINAL MESH EXPOSURE AND PELVIC PAIN, URINARY INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    DETAILS: IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE EXPOSED MESH, REVISION OF THE ARMS OF THE MESH AND CYSTOSCOPY ON (B)(6) 2012 BY DR. (B)(6) DUE TO VAGINAL MESH EXPOSURE AND PELVIC PAIN, URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252499 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL FTL ETHICON, INC. NA 2983129

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention