BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2881305 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08185
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY DURING MESH IMPLANTATION. THE PATIENT REPORTED PAIN, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, FISTULAE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, AND OTHER FOLLOWING IMPLANTATION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ANTERIOR WALL PROLAPSE AND VAGINAL SCARRING AND UNDERWENT MESH REVISION ON (B)(6) 2010. THERE WAS AN AREA OF THICKENED SCAR TISSUE AROUND THE URETHRA WITH ADVERTENT CUTTING OF ¼ OF SUB URETHRAL MESH WHICH WAS RE-APPROXIMATED ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED (B)(4) - URINARY PROBLEMS; BOWEL PROBLEMS; DYSPAREUNIA; NEUROMUSCULAR PROBLEMS; PROLAPSE.

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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 INC NA 2973019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention