BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3041962 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03619
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    June 12, 2009
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED HEMATURIA, URINARY FREQUENCY, URINARY LEAKAGE, URINARY RETENTION, PELVIC PAIN, STRESS INCONTINENCE, CYSTOCELE, AND POSTVOID DRIBBLING.

    Additional Manufacturer Narrative · 1

    (B)(4) - UNSUCCESSFUL ATTEMPT TO IMPLANT THE DEVICE OCCURRED DUE TO PATIENT'S MULTIPLE PREVIOUS SURGERIES.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 2210968-2012-03455. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2009. DURING THE PROCEDURE, THE SURGEON'S ATTEMPTS TO DISSECT THE VAGINAL SKIN AWAY FROM URETHRA WERE UNSUCCESSFUL DUE TO LOSS OF PLANE, WHICH WAS LIKELY BECAUSE OF THE PATIENT'S MULTIPLE PREVIOUS SURGERIES. INITIAL ATTEMPTS TO PLACE THE URETHRAL SLING WERE UNSUCCESSFUL AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A PELVIC FLOOR REPAIR MESH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED HEMATURIA, URINARY FREQUENCY, URINARY LEAKAGE, URINARY RETENTION, PELVIC PAIN, STRESS INCONTINENCE, CYSTOCELE, AND POSTVOID DRIBBLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145722 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3116361

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention