BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972846 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01436
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    04/22/2013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE CHRONIC PELVIC PAIN AND IS NOW EXPERIENCING STRESS URINARY INCONTINENCE ON (B)(4) 2012. THE PATIENT WAS REFERRED TO CHRONIC PAIN CLINIC FOR TREATMENT AND PHYSIOTHERAPY. AN ULTRASOUND IS PLANNED TO SEE IF THERE IS ANY RETAINED MESH. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION TO TREAT STRESS URINARY INCONTINENCE. POST IMPLANTATION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, NEUROMUSCULAR PROBLEMS, AND VAGINAL SCARRING. ON (B)(6) 2012, THE PATIENT UNDERWENT REPAIR AND TRIMMING OF MESH DUE TO MESH EROSION. ON (B)(6) 2013, THE PATIENT UNDERWENT REMOVAL OF MESH DUE TO EROSION, CONSTANT PAIN AND INFECTIONS. (B)(4) ¿ URINARY PROBLEMS; RECURRENCE; NEUROMUSCULAR PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75528 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3510641

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention