BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3150498 · Received June 6, 2013

    Report

    Report Number
    2210968-2013-06685
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY.

    Additional Manufacturer Narrative · 1

    (B)94). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH LAVH; DUE TO SUI WITH INTRINSIC SPHINCTER DEFICIENCY AND PREVIOUS ECTOPIC PREGNANCY WITH KNOWN ABDOMINAL ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SUBURETHRAL DISSECTION, RELEASE OF SCAR TISSUE, URETHRAL DILATION AND CYSTOSCOPY ON (B)(6) 2010 DUE TO RECURRENT URINARY TRACT INFECTIONS AND URINARY URGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT RESECTION OF THE MESH ON (B)(6) 2010 DUE TO URINARY RETENTION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A RESECTION OF MESH ON (B)(6) 2011 DUE TO EROSION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT BURCH COLSUSPENSION SURGERY ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH LYSIS OF ADHESIONS DURING MESH IMPLANTATION. THE PATIENT EXPERIENCED MESH EROSION, PAIN, INFECTION, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES, INCLUDING REPAIR SURGERIES ON (B)(6) 2010 AND (B)(6) 2010. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH LYSIS OF ADHESIONS AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MESH EROSION, PAIN, INFECTION, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES, INCLUDING REPAIR SURGERIES ON (B)(6) 2010. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250018 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3370791

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention