BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 3150566 · Received June 6, 2013

    Report

    Report Number
    2210968-2013-06572
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K851086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT THE MESH IMPLANTATION FOR A GRADE III VAGINAL PROLAPSED AFTER HYSTERECTOMY. STRESS URINARY INCONTINENCE, AND AN ABDOMINAL ENTEROCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERNAL HERNIA, SEGMENTAL GANGRENE OF THE DISTAL SMALL BOWEL, INTRAPERITONEAL FOREIGN BODY, PERITONEAL ADHESION, AND UNDERWENT REMOVAL OF FOREIGN BODY, REPAIR OF VAGINAL CUFF ON (B)(6) 2012. THE PATIENT ALSO EXPERIENCED POST HYSTERECTOMY VAGINAL VAULT PROLAPSE AND UNDERWENT COMBINED ANTERIOR AND POSTERIOR REPAIR WITH AN ENTEROCLE REPAIR, BILATERAL UTEROSACRAL VAGINAL VAULT SUSPENSION ON (B)(6) 2012 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ABDOMINAL COLPOSACROPEXY, ABDOMINAL ENTEROCELE REPAIR, AND PARAVAGINAL BLADDER SUSPENSION. THE PATIENT UNDERWENT POSTERIOR COLPORRHAPHY ON (B)(6) 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT 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
    250544 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention