BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2973758 · Received February 22, 2013

    Report

    Report Number
    2210968-2013-01601
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 29, 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). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2005 BY DR. (B)(6) TO TVT SLING EROSION AT (B)(6) HOSPITAL. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION AND CYSTOSCOPY ON (B)(6) 2006 BY DR. (B)(6) TO SLING EROSION, FEMALE STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY AT (B)(6) HOSPITAL. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2010 BY DR. (B)(6) TO EROSION OF SUBURETHRAL SLING. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2004 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78401 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1098371

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention