BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2183023 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-01020
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC PROLAPSE. THE PATIENT UNDERWENT PARTIAL EXPLANT SURGERY DUE TO EROSION AND IMPROPER HEALING ON (B)(6) 2010. THE PATIENT UNDERWENT EXPLANT SURGERY ON (B)(6) 2011 DUE TO EROSION, INFECTION, DYSPAREUNIA, VAGINAL PAIN AND BOWEL PAIN. THE PATIENT UNDERWENT EXPLANT SURGERY ON (B)(6) 2012 DUE TO REMAINING PIECES OF MESH CAUSING AN ABSCESS. (B)(4).

    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. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM: PRODUCT CODE: PFRA01; (B)(4). GYNECARE TVT OBTURATOR: PRODUCT CODE: 810081; BATCH UNKNOWN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHRAL DILATATION AND MESH REMOVAL ON (B)(6) 2014 DUE TO RECURRENT UTI, SEVERE URETHRAL STENOSIS AND EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY GYNECOLOGICAL PROCEDURE ON (B)(6) 2009. DURING THE PROCEDURE, PELVIC FLOOR MESH AND A SLING WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, DYSPAREUNIA, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR