BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3023755 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02930
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT UMBILICAL HERNIORRHAPHY, VENTRAL HERNIORRHAPHY, SHORTENING OF THE UTEROSACRAL LIGAMENTS FOR APICAL VAGINAL SUSPENSION, COLPOPEXY, B/L PARAVAGINAL DEFECT REPAIR, RETROPUBIC URETHROPEXY, SUPRAPUBIC CYSTOSTOMY, CYSTOSCOPY AND EXTENSIVE ENTEROLYSIS WITH RELEASE OF BAND AND LOOP FORMATION ON (B)(6) 2014 DUE TO PELVIC FLOOR RELAXATION, APICAL VAGINAL PROLAPSE, B/L PARAVAGINAL DEFECT, SUI, VENTRAL AND UMBILICAL HERNIA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR REPAIR. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A HYSTERECTOMY, CYSTOSCOPY, AND PERINEORRHAPHY. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF AVAULTA MESH ON (B)(6) 2007; VNUS LEFT LOWER EXTREMITY WITH STAB PHLEBECTOMY, AND REVISION OF AVAULTA MESH OF THE ANTERIOR VAGINAL WALL ON (B)(6) 2007; VAGINAL EXCISION OF ERODED MESH AND PERINEOPLASTY ON (B)(6) 2008; VAGINAL EXCISION OF ERODED AVAULTA MESH ON (B)(6) 2012.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH, AVAULTA AND URETEX WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126130 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention URETEX