BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2831348 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07110
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT HER BLADDER WAS REPAIRED THREE TIMES IN 1986, 1996, AND 2009. THE PATIENT UNDERWENT MESH REVISION AND CLOSURE OF MUCOSA ON (B)(6) 2012 DUE TO EXPOSED VAGINAL MESH. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DUE TO MESH EXPOSURE, AND BLEEDING, PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012. (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/POSTERIOR REPAIR AND EXTRAPERITONEAL COLPOPEXY DUE TO STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY LEAKAGE AND URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ORGAN PERFORATION, BLEEDING, VAGINAL IRRITATION, VAGINAL DISCHARGE, OVERACTIVE BLADDER, AND URINARY TRACT INFECTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07111. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY LEAKAGE AND URINARY INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ORGAN PERFORATION, BLEEDING, VAGINAL IRRITATION, VAGINAL DISCHARGE, OVERACTIVE BLADDER, AND URINARY TRACT INFECTIONS.

    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 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3193468

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention