BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2063464 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00429
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). DRS. (B)(6). THE PATIENT HAD A MESH REVISION ON (B)(6) 2009, BUT THE MESH COULD NOT BE REMOVED, AS TISSUE HAD GROWN AROUND IT. THE PATIENT HAD A MESH REMOVAL SURGERY ON (B)(6) 2010 DUE TO PAIN, VAGINAL MESH EROSION, PAIN IN LEGS, AND DYSPAREUNIA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2003 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON NA 1051052

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention