BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2931333 · Received January 28, 2013

    Report

    Report Number
    2210968-2013-00593
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE AND CYSTOCELE. THE PATIENT EXPERIENCED DIFFICULTY URINATING, INCREASED URINARY INCONTINENCE, URINARY RETENTION, PAINFUL INTERCOURSE, CHRONIC URINARY TRACT INFECTIONS, CHRONIC BLADDER INFECTIONS, WHEN SITTING SHE DOES NOT FEEL THE URGE TO URINATE, AND WHEN SHE STANDS UP SHE WETS HERSELF. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY WITH URETHROLYSIS AND EXCISION OF URETHRAL BAND ON (B)(6) 2016 BY DR. (B)(6), MD DUE TO URINARY RETENTION WITH HISTORY OF PREVIOUS TVT SLINGS. IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY AND FREQUENCY. (B)(4).

    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.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY WITH URETHROLYSIS AND EXCISION OF URETHRAL BAND ON (B)(6) 2016 BY DR. (B)(6), MD DUE TO URINARY RETENTION WITH HISTORY OF PREVIOUS TVT SLINGS. IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY AND FREQUENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 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 MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36957 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1152451

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention