BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3214051 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12671
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    December 7, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO SYMPTOMATIC PELVIC RELAXATION, VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE ALONG WITH CONCURRENT TRANSURETHRAL BLADDER NECK SUSPENSION, LEFT INGUINAL HERNIORRHAPHY AND VAGINAL VAULT SUSPENSION BY SACRAL SPINAL MESH COLPOPEXY. IT WAS ALSO REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, RECURRENCE AND NEUROMUSCULAR PROBLEMS. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2011 DUE TO REPAIR OF RECTOCELE OPENING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2009 DUE TO LEFT INCARCERATED INGUINAL HERNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT PLACEMENT OF BARD MESH PERFIX PLUG ON (B)(6) 2009, ALONG WITH MESHES. IT WAS REPORTED THAT THE PATIENT UNDERWENT BOSTON SCIENTIFIC ADVANTAGE FIT ON (B)(6) 2011, ALONG WITH COMPLETE COLPOCLEISIS & ENTEROCELE REPAIR. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO SYMPTOMATIC PELVIC RELAXATION, VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE ALONG WITH CONCURRENT TRANSURETHRAL BLADDER NECK SUSPENSION, LEFT INGUINAL HERNIORRHAPHY AND VAGINAL VAULT SUSPENSION BY SACRAL SPINAL MESH COLPOPEXY. IT WAS ALSO REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, RECURRENCE AND NEUROMUSCULAR PROBLEMS. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2011 DUE TO REPAIR OF RECTOCELE OPENING. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313651 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3308215

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention BARD MESH PERFIX PLUG