BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2980185 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01633
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 4, 2013
    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

    (B)(4): 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

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED DUE TO POP. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF AVAULTA MESH ON (B)(6) 2009 DUE TO EROSION AND REMOVAL OF AVAULTA MESH ON (B)(6) 2012 DUE TO DYSPAREUNIA AND EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION/REMOVAL ON (B)(6) 2013 DUE TO EROSION. (B)(4) - URINARY/BOWEL PROBLEMS; UNDEFINED RECURRENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND MONARC WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCHARGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A SLING AND THE AVAULTA PLUS ANTERIOR SUPPORT SYSTEM AND THE AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM WERE 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
    84021 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3222315

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention AVAULTA PLUS POST BIOSYNTHETIC SUPPORT SYS| MONARCH