BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2113235 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00704
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN (B)(6) 2007 FOR STRESS INCONTINENCE. AT (B)(6) POST OP, THE PATIENT WAS SEEN BY THE SURGEON. SHE HAD NO SPECIFIC COMPLAINTS AND THE SURGICAL PAIN AND STRESS INCONTINENCE WERE RELIEVED. IN (B)(6) 2008 THE PATIENT VISITED THE SURGEON COMPLAINING OF PELVIC PAIN AND DYSPAREUNIA. IT WAS REPORTED THAT MESH HAD ERODED INTO TISSUE. SHE SAW A DIFFERENT SURGEON AND HAD THE SLING REMOVED IN (B)(6) 2008. THE PAIN RESOLVED AT THAT TIME, BUT STRESS INCONTINENCE RETURNED. PATIENT REPORTEDLY HAD ANOTHER SURGICAL PROCEDURE IN (B)(6) 2009. THE PRODUCT UTILIZED AT THAT TIME WAS NOT IDENTIFIED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention