BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3030860 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03291
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    August 7, 2019
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS, RECURRENCE, AND DYSPAREUNIA. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, URINARY TRACT INFECTION, URGE INCONTINENCE AND BURNING SENSATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOURETHROSCOPY. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 8/7/2019. (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ABDOMINAL PAIN, URINARY RETENTION, HEMATURIA, ADHESIONS, SCARRING AND BLADDER SPASM. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISIONS ON (B)(6) 2014, (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2017. (B)(4) REPRESENTS THE ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2014. (B)(4) REPRESENTS THE ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2015. (B)(4) REPRESENTS THE ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2016. (B)(4) REPRESENTS THE ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A SLING 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
    133666 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3472259

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention