BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7979686 · Received October 18, 2018

    Report

    Report Number
    2210968-2018-76630
    Event Type
    Injury
    Date Received
    October 18, 2018
    Report Date
    September 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TENSION FREE VAGINAL TAPE - OBTURATOR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: GYNECOLOGY 2015 · 48: 164-168; DOI 10.1007/S00129-014-3515-9 . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPLICATIONS FOLLOWING A SUBURETHRAL SLING OPERATION". AUTHOR(S): A.R. MOTHES · M.P. RADOSA · I.B. RUNNEBAUM. CITATION: GYNECOLOGY 2015 · 48: 164-168; DOI 10.1007/S00129-014-3515-9. THIS CASE REPORT AIMED TO PRESENT A (B)(6) FEMALE PATIENT WHO UNDERWENT SUBURETHRAL, TRANSOBTURATOR SLING IMPLANT USING TVTTM OBSTURATOR SYSTEM (ETHICON) FOR PERSISTENT SECOND GRADE DETRIMENTAL URINARY INCONTINENCE. POSTOPERATIVELY DAY 6, THE PATIENT EXHIBITED RENEWED CLINICAL SWELLING AND REDNESS ON BOTH INNER THIGHS DIAGNOSED AS TYPE 1 NECROTIZING FASCIITIS ON HISTOPATHOLOGY. SHE WAS TREATED WITH REMOVAL OF ALLOPLASTIC MATERIALS (TVT) AND RELIEF INCISIONS MADE IN THE PROXIMAL THIRD OF BOTH INNER THIGHS UNDER CONTINUOUS INTRAVENOUS ANTIBIOTIC TREATMENT. DEBRIDEMENT AND REMOVAL OF NECROSIS WERE PERFORMED. FURTHER TREATMENT INCLUDED FOUR COURSES OF DEBRIDEMENT AND THERAPY WITH VACUSEAL NEGATIVE PRESSURE WOUND DRESSINGS, THE WOUND WAS CLOSED WITH SECONDARY SUTURES. FOLLOW UP MONITORING AT 4-WEEK INTERVALS REVEALED NO LOCAL IRRITATION. A MICROBIAL MIXED INFECTION IN THE OPERATION AREA WAS PROVEN TO BE THE CAUSE IN THE CASE PRESENTED. THIS CORRESPONDS WITH THE CAUSAL LINK BETWEEN ENTEROCOCCAL INFECTION AND NECROTIZING FASCIITIS. THE LOCATION OF THE ALLOPLASTIC MATERIALS IN TVT IMPLANTS IN THE AREA OF THE PELVIC FLOOR COULD POSSIBLY BE SEEN AS A RISK FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819311 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention