BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3070877 · Received April 22, 2013

    Report

    Report Number
    2210968-2013-04222
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, RECURRENCE, BLEEDING AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2013, ALONG WITH LAPAROSCOPIC BURCH & CYSTOURETHROSCOPY; DUE TO SLING OBSTRUCTION, SEAM EROSION AND STRESS INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, POSTERIOR REPAIR, AND PERINEOPLASTY DUE TO STRESS INCONTINENCE ALONG WITH LAX VAGINAL INTROITUS.

    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

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAINFUL MENSES, DYSURIA, URINARY TRACT INFECTION, FREQUENT VAGINAL YEAST INFECTIONS, VAGINAL IRRITATION, POSTCOITAL VAGINAL SPOTTING, PELVIC PAIN, URINARY FREQUENCY, AND URINARY URGENCY.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAINFUL MENSES, DYSURIA, URINARY TRACT INFECTION, FREQUENT VAGINAL YEAST INFECTIONS, VAGINAL IRRITATION, POSTCOITAL VAGINAL SPOTTING, PELVIC PAIN, URINARY FREQUENCY, AND URINARY URGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172103 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC NA 3238430

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention