BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3131796 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-06021
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2002 AND MESH EXCISION ON (B)(6) 2002 DUE TO EXTRUSION AND EROSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH AND THE AMS SPARC WERE IMPLANTED DUE TO STRESS URINARY INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE ON (B)(6) 2007 AND TWO BOSTON SCIENTIFIC COAPTITE URETHRAL INJECTIONS WERE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH AND THE AMS SPARC WERE 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
    236802 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention