BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2851139 · Received November 29, 2012

    Report

    Report Number
    2210968-2012-07612
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND VAGINAL PROLAPSE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PATIENT EXPERIENCED PAINFUL INTERCOURSE AND MESH EROSION. THE PATIENT UNDERWENT SURGERY TO TRIM MESH DUE TO EROSION ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT UTEROSACRAL CUFF SUSPENSION, CYSTOSCOPY, AND ANTERIOR COLPORRHAPHY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, UTIS 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 THE PATIENT CONCURRENTLY UNDERWENT UTEROSACRAL CUFF SUSPENSION, CYSTOSCOPY, AND ANTERIOR COLPORRHAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 3019333

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention