BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2800177 · Received October 22, 2012

    Report

    Report Number
    2210968-2012-06784
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005 CONCURRENTLY WITH A HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2005 BY DR. (B)(6) DUE TO MESH BAND AT THE VAGINAL APEX, RETENSION AFTER PLACEMENT OF MESH SLING AND ON (B)(6) 2007 BY DR. (B)(6) DUE TO VAGINAL BANDING AT APEX SECONDARY TO MESH, DEEP DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PRESSURE SENSATION IN HER PERINEUM.

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06781, AND 2210968-2012-06782. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2005 BY DR. (B)(6) DUE TO MESH BAND AT THE VAGINAL APEX, RETENSION AFTER PLACEMENT OF MESH SLING AND ON (B)(6) 2007 BY DR. (B)(6) DUE TO VAGINAL BANDING AT APEX SECONDARY TO MESH, DEEP DYSPAREUNIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PRESSURE SENSATION IN HER PERINEUM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention