BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3151458 · Received June 7, 2013

    Report

    Report Number
    2210968-2013-06706
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHROLYSIS/REMOVAL OF OBSTRUCTING SLING AND REMOVAL OF EXTRUDED MESH ON (B)(6) 2012 BY DR. (B)(6) DUE TO EXTRUDED VAGINAL MESH, OBSTRUCTING MID URETHRAL SLING AND CYSTOCELE.

    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. 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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOCELE REPAIR, ENTEROCELE REPAIR, SACROSPINOUS LIGAMENT FIXATION AND POSTERIOR REPAIR WITH POSTERIOR COLPOPINEORRHAPHY; DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2010. ON (B)(6) 2012, THE PATIENT UNDERWENT ANTERIOR ELEVATE PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REMOVAL ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND (B)(6) 2012 AND MESH AND ELEVATE WERE IMPLANTED. DATES NOT CLARIFIED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHROLYSIS/REMOVAL OF OBSTRUCTING SLING AND REMOVAL OF EXTRUDED MESH ON (B)(6) 2012 BY DR. (B)(6) DUE TO EXTRUDED VAGINAL MESH, OBSTRUCTING MID URETHRAL SLING AND CYSTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252648 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3323235

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention