BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2831575 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07138
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. ON (B)(6) 2012 THE PATIENT UNDERWENT A REMOVAL OF MIDURETHRAL SLING. ON (B)(6) 2012 THE PATIENT UNDERWENT LAPAROSCOPIC HELLER MYOTOMY WITH ANTERIOR DOR FUNDOPLASTY. 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 2210968-2015-06536. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTIONS, DYSURIA, HEMATURIA, VAGINAL DISCHARGE, INCONTINENCE AND FREQUENCY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PUBOVAGINAL SLING WITH AUTOLOGOUS FASCIA AND VIDEO CYSTOURETHROSCOPY ON (B)(6) 2014 BY DR. (B)(6) DUE TO REFRACTORY URINARY INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PUBOVAGINAL SLING WITH AUTOLOGOUS FASCIA AND VIDEO CYSTOURETHROSCOPY ON (B)(6) 2014 BY DR. (B)(6) DUE TO REFRACTORY URINARY INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2010 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, MESH EROSION, INFECTION, DYSPAREUNIA, AND SHE 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3398077

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention