BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972239 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01510
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PROLAPSE, STRESS URINARY INCONTINENCE, URINARY FREQUENCY, CYSTOCELE, RECTOCELE AND URINARY OBSTRUCTION. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, VAGINAL SCARRING, ORGAN PERFORATION AND URINARY AND NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL VAULT SUSPENSION TO THE RIGHT SACROSPINOUS LIGAMENT, ENTEROCELE REPAIR WITH HIGH LIGATION OF THE ENTEROCELE SAC, ANTERIOR AND POSTERIOR COLPOPERINEORRHAPHY AND CYSTOSCOPY ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2006. (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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH REMOVAL OF MESH FROM THE ANTERIOR WALL OF THE VAGINA, TRANSOBTURATOR MESH INSERTION AND CYSTOSCOPY DUE TO EROSION OF VAGINAL MESH, STRESS URINARY INCONTINENCE.

    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 THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01509 AND MEDWATCH 2210968-2012-01511. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DIFFICULTY EMPTYING BLADDER, FREQUENCY AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A 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
    76876 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2934498

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention