BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3141459 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06355
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ON (B)(6) 2001 DUE TO STRESS URINARY INCONTINENCE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, ADHESIONS AND URETHRAL DIVERTICULUM. IT WAS REPORTED THAT PATIENT UNDERWENT THE FOLLOWING PROCEDURES: (B)(6) 2007: TRANSVAGINAL URETHROLYSIS DUE TO SIGNIFICANT OBSTRUCTIVE VOIDING SYMPTOMS FOLLOWING MESH PROCEDURE; (B)(6) 2009: INTERSTIM SCARAL NEUROMODULATION STAGE I AND II DUE TO REFRACTORY URINARY URGE INCONTINENCE; (B)(6) 2011: INTERSTIM LEAD REMOVAL AND REPLACEMENT, USING FLUOROSCOPIC GUIDANCE DUE TO MALFUNCTIONING INTERSTIM LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    244854 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 889492

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention