BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2861670 · Received December 7, 2012

    Report

    Report Number
    2210968-2012-07971
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    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). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOCELE REPAIR WITH SACROSPINOUS FIXATION. ON (B)(6) 2011 THE PATIENT UNDERWENT AN EXCISION OF EXPOSED VAGINAL MESH AND EXCISION OF LEFT LABIAL CYST. IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL SACROSPINOUS LIGAMENT, VAGINAL SUSPENSION, ANTERIOR COLPORRHAPHY, AND ENTEROCELE REPAIR, RETROPUBIC MID URETHRAL SLING PLACEMENT OF BOSTON SCIENTIFIC ADVANTAGE FIT, AND CYSTOURETHROSCOPY ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT BSO IN 2008.

    Additional Manufacturer Narrative · 1

    IN ADDITION, 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) 2006 AND A SLING AND PELVICOL ACELLULAR COLLAGEN MATRIX WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 2933520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention