BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3241068 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-13996
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 28, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED DUE TO URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL PAIN, LOWER ABDOMINAL CRAMPING AND PAINFUL INTERCOURSE. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH VENTRALEX MESH ON (B)(6) 2010 DUE TO RECURRENT INCISIONAL HERNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS, RESECTION OF SMALL BOWEL FISTULA WITH PRIMARY SMALL BOWEL CLOSURE, DRAINAGE OF ABDOMEN AND UMBILICAL SKIN AND CLOSURE OF WOUND ON (B)(6) 2011 DUE TO RECURRENT INCISIONAL HERNIA, STATUS POST MESH PLACEMENT, EXTENSIVE INTRA-ABDOMINAL ADHESIONS AND ENTEROCUTANEOUS FISTULA FROM SMALL BOWEL ADHERENT TO MESH EXITING AT UMBILICAL SKIN. IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REPAIR OF INCARCERATED INCISIONAL HERNIA WITH MESH PLACEMENT ON (B)(6) 2009 DUE TO INCISIONAL HERNIA. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS, RESECTION OF SMALL BOWEL FISTULA WITH PRIMARY SMALL BOWEL CLOSURE, DRAINAGE OF ABDOMEN AND UMBILICAL SKIN AND CLOSURE OF WOUND ON (B)(6) 2011 DUE TO RECURRENT INCISIONAL HERNIA, STATUS POST MESH PLACEMENT, EXTENSIVE INTRA-ABDOMINAL ADHESIONS AND ENTEROCUTANEOUS FISTULA FROM SMALL BOWEL ADHERENT TO MESH EXITING AT UMBILICAL SKIN. IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REPAIR OF INCARCERATED INCISIONAL HERNIA WITH MESH PLACEMENT ON (B)(6) 2009 DUE TO INCISIONAL HERNIA. NO ADDITIONAL INFORMATION.

    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

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE 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
    341336 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3342365

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention