BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2973310 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01524
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE WITH URETHRAL HYPERMOBILITY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED WORSENING INCONTINENCE, WORSENING DYSPAREUNIA, CHRONIC PELVIC PAIN, RECURRENT URINARY TRACT INFECTIONS, RECURRENT BLADDER INFECTIONS, BLADDER SPASMS, PAINFUL INTERCOURSE, URINE LEAKAGE, URGENCY, CONSTANT DAMPNESS FROM INCONTINENCE, AND A URETHRAL OBSTRUCTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO URETHRAL OBSTRUCTION AND INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF CYSTOSCOPY DURING SUBURETHRAL MESH IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, THE PATIENT 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
    75870 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3256679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention