BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2932887 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00589
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2010 DUE TO RECURRENCE OF INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF IMPLANTABLE PULSE GENERATOR AND QUADRIPOLAR LEAD ON (B)(6) 2012 DUE TO BACK PAIN, NEUROGENIC BLADDER AND URGE INCONTINENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHROLYSIS, RE-DO TRANSVAGINAL TAPE, OBTURATOR APPROACH ON (B)(6) 2010. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/03/2016. ADDITIONAL INFORMATION: AGE/DATE OF BIRTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39345 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 860586

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention