BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2900008 · Received January 7, 2013

    Report

    Report Number
    2210968-2013-00150
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-03401. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/22/2015. 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 SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH AND A SLING WERE IMPLANTED CONCURRENTLY WITH SURGICAL PROCEDURES LAVH/BSO, LYSIS OF ADHESIONS, SACROCOLPOPEXY, MCCALL¿S CULDOPLASTY, ANTERIOR COLPORRHAPHY AND CYSTOURETHROSCOPY; DUE TO UTEROVAGINAL PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, BLEEDING, VAGINAL SCARRING/SHRINKAGE AND EXPOSURE/EXTRUSION/PROTRUSION, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT ALSO WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2012 AND AN UNKNOWN BOSTON SCIENTIFIC PRODUCT WAS IMPLANTED. IT WAS REPORTED THAT DUE TO PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE AND PARAVAGINAL DEFECT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 AS WELL. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND AN OBTURATOR SLING WAS IMPLANTED. CONCOMITANTLY, THE PATIENT UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, SACROCOLPOPEXY, MCCALL'S CULDOPLASTY, ANTERIOR COLPORRHAPHY AND CYSTOURETHROSCOPY. THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, BLEEDING, VAGINAL SCARRING/SHRINKAGE AND EXPOSURE/EXTRUSION/PROTRUSION, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. DUE TO PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE AND PARAVAGINAL DEFECT, THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7835 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3512145

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention