BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7223549 · Received January 26, 2018

    Report

    Report Number
    2210968-2018-70490
    Event Type
    Injury
    Date Received
    January 26, 2018
    Report Date
    January 3, 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). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: TAIWANESE JOURNAL OF OBSTETRICS & GYNECOLOGY 51 (2012) 283-284. DOI:10.1016/J.TJOG.2012.04.021.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿TITLE: PELVIC FLOOR ABSCESS SECONDARY TO GOSSYPIBOMA FOLLOWING A TOTAL PROLIFT PROCEDURE¿ THAT THE PATIENT UNDERWENT SURGICAL PROCEDURE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MESH EROSION RESULTING FROM GOSSYPIBOMA. THE PATIENT REPORTED INTERMITTENT VAGINAL DISCHARGE AND FEVER DURING THE FIRST POSTOPERATIVE FOLLOW-UP (POSTOPERATIVE DAY 12). PELVIC EXAMINATION SHOWED 1-1.5 CM OF MESH EROSION IN THE MIDLINE OF THE ANTERIOR VAGINA INCISION WITHOUT POP RECURRENCE. ALTHOUGH VAGINAL DOUCHE WITH GENTAMICIN 80MG IN THE OUTPATIENT DEPARTMENT AND 3 COMBINATIONS OF ANTIBIOTICS (METRONIDAZOLE 250MG, SULBACTAM SODIUM/AMPICILLIN SODIUM 375MG, LEVOFLOXACIN 500MG) WERE USED, MALODOR OF VAGINAL DISCHARGE PERSISTED FOR 7 DAYS. THE EXPOSED MESH WAS JUST TRIMMED AND THE VAGINAL MUCOSA WAS RESUTURED DUE TO LIMITED EXPOSURE AREA. MUCH PUS WAS DRAINED SPONTANEOUSLY, AND CULTURED MEDIUM SHOWED ESCHERICHIA COLI COLONIZATION. AFTER 2 WEEKS OF ALLEVIATION FROM FEVER, THE PATIENT REPORTED SOME DISCHARGE COMING OUT OF THE VAGINA AGAIN. AFTER INCISION AND DISSECTION OF THE VAGINAL WOUND, ONE PIECE OF GAUZE WAS SEEN IN THE PARAVESICAL SPACE. THE GAUZE WAS TAKEN OUT AND PART OF THE MESH WAS EXCISED. AFTER DEBRIDEMENT, NO FURTHER FEVER AND MALODOROUS DISCHARGE WAS NOTED. THE PATIENT HAS REMAINED CONTINENT AND FREE OF POP FOR OVER 1 YEAR AT THE TIME OF WRITING. IT WAS REPORTED THAT ¿THERE IS NO DOUBT THAT A RETAINED GAUZE CONTRIBUTED TO POOR HEALING OF THE VAGINAL WOUND FOLLOWING MESH SURGERY, MAKING THE EXPOSURE OF MESH MORE LIKELY¿. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65045 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention