BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3161354 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-06934
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2010 DUE TO EROSION .

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH BLADDER NECK SUSPENSION DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS AND BLEEDING. ON (B)(6) 2010, THE PATIENT UNDERWENT REVISION OF MESH AND TRIMMING OF EXTRA MESH DUE TO EXPERIENCED PULLING ON MESH. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2009 DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS AND DYSPAREUNIA. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262881 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3322090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention