BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2780857 · Received October 10, 2012

    Report

    Report Number
    2210968-2012-06281
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT POST IMPLANTATION, THE PATIENT EXPERIENCED INFECTION, URINARY AND BOWEL DISTURBANCE AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL IN 2006. (B)(4) ¿URINARY DISTURBANCE; BOWEL DISTURBANCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED DUE TO RECURRENT STRESS URINARY INCONTINENCE. PATIENT ALSO HAD A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED DUE TO VAGINAL VAULT PROLAPSE, CYSTOCELE AND RECTOCELE REPAIR. (B)(4). THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06279, 2210968-2012-06280, 2210968-2013-24425, AND 2210968-2013-33881. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06279 AND 2210968-2012-06280. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY HESITANCY, DYSURIA, URINARY FREQUENCY, VAGINAL DISCOMFORT WITH PRESSURE AND URINARY TRACT INFECTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, URINARY HESITANCY, DYSURIA, URINARY FREQUENCY, VAGINAL DISCOMFORT WITH PRESSURE AND URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1279501

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention