BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2980907 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01727
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2002 IN ORDER TO TREAT CYSTOCELE, RECTOCELE, AND ENTEROCELE CONCURRENTLY WITH ANTERIOR REPAIR, POSTERIOR REPAIR, ENTEROCELE REPAIR, AND PERINEORRHAPHY. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTOURETHROSCOPY AND PLACEMENT OF BILATERAL CATHETERS ON (B)(6) 2003. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL/REVISION AND ANTERIOR COLPORRHAPHY, CYSTOCELE REPAIR WITH ALLODERM PLACEMENT ON (B)(6) 2011 DUE TO MESH EROSION AND ANTERIOR VAGINAL PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED. (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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01726. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2011.THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01726. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSURIA, HEMATURIA, PYURIA, AND URINARY FREQUENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, BURNING AND URINARY INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    84623 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 925524

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention