BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2945634 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00809
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED CONCURRENTLY WITH BOSTON SCIENTIFIC /PINNACLE PRODUCT IMPLANTED AND HYSTERECTOMY, DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INSERTION OF AN UNKNOWN MESH ON (B)(6) 2010. IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR COLPORRHAPHY AND REPAIR OF ENTEROCELE, ON (B)(6) 2010 DUE TO CHRONIC PELVIC PAIN, SYMPTOMATIC RECTOCELE, SYMPTOMATIC ENTEROCELE, PELVIC ADHESIONS AND ENDOMETRIOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES ON (B)(4) 2007 AND (B)(6) 2010 AND PINNACLE AND A SLING WERE IMPLANTED. IT IS UNKNOWN WHAT PRODUCT WAS IMPLANTED IN EACH PROCEDURE. IT WAS REPORTED THAT SHE 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
    50011 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2952017

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention