BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3241626 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-14037
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 16, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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). 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF INCISIONAL RECURRENT HERNIA WITH MESH (MARLEX MESH MEASURING 6 X 11 CM) ON (B)(6) 2008 DUE TO RECURRENT HERNIA IN LOWER ABDOMINAL SCAR FROM PRIOR ABDOMINOPLASTY STATUS POST PRIOR REPAIR OF HERNIA IN THE SAME LOCATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, ANTERIOR/POSTERIOR COLPORRHAPHY, SUPRAPUBIC CATHETER INSERTION, HERNIORRHAPHY DUE TO IRREGULAR UTERINE BLEEDING, PELVIC PAIN, SUI, CYSTOCELE, RECTOCELE AND INCISIONAL HERNIA. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT INCISIONAL HERNIA REPAIR WITH MESH WITH A VENTRALEX PATCH AND EXCISION OF SOME REDUNDANT SKIN. IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH MESH ON (B)(6) 2007 DUE TO INCISIONAL HERNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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
    341237 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1265960

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention