BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3132300 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05923
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    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). 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTEROSCOPY; AND D&C WITH NOVASURE ENDOMETRIAL ABLATION DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC PAIN AND VAGINAL AREA PAIN AS WELL AS SEVERE MESH EROSION, VAGINAL BLEEDING, PELVIC INFLAMMATION, DYSPAREUNIA, FREQUENT INFECTION, SEVERE HIP PAIN AND EXCRUCIATING PAIN DURING INTERCOURSE. THE PATIENT EXPERIENCED THE PAIN AND TRAUMA OF SEVERAL ADDITIONAL SURGERIES TO REMOVE AND REVISE THE MESH IN HOPES OF ALLEVIATING SOME OF THE PAIN AND SUFFERING. THE PATIENT SUFFERED PSYCHOLOGICALLY AND EMOTIONALLY. THE PATIENT UNDERWENT LAPAROSCOPIC VAGINAL HYSTERECTOMY ON (B)(6) 2009. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL MESH REMOVAL ON (B)(6) 2011. IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL MESH REMOVAL ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES, AND 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
    236312 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3222339

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention