BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3131859 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-06037
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2006 DUE TO EXPOSED MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2006 IN ORDER TO TREAT STRESS URINARY INCONTINENCE CONCURRENTLY WITH THE REMOVAL OF A 2 CM VAGINAL POLYP (BENIGN) AND A CYSTOSCOPY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, STRESS URINARY INCONTINENCE, URGE INCONTINENCE, URINARY PROBLEMS, AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2006 DUE TO EXPOSED MESH CONCURRENTLY WITH A CYSTOURETHROSCOPY AND URETHROLYSIS. IT WAS REPORTED THAT FOLLOWING MESH REMOVAL THE PATIENT EXPERIENCED MIXED STRESS URINARY INCONTINENCE AND URGE INCONTINENCE WITH INTRINSIC URETHRAL SPHINCTER DEFICIENCY. A TRANSURETHRAL INJECTION OF COAPTITE WAS PERFORMED WITH A CYSTOSCOPY ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 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
    235127 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1379679

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention