BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 8044194 · Received November 6, 2018

    Report

    Report Number
    2210968-2018-76992
    Event Type
    Injury
    Date Received
    November 6, 2018
    Report Date
    October 22, 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: JOURNAL OF OBSTETRICS AND GYNAECOLOGY. 2013; 33: 908¿915. DOI: 10.3109/01443615.2013.823925. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "VULVAL HAEMATOMA AFTER TVT-OBTURATOR INSERTION REQUIRING ARTERIAL EMBOLISATION," AUTHORS: I. KRYNYTSKA, R. HOLMES. CITATION: JOURNAL OF OBSTETRICS AND GYNAECOLOGY. 2013; 33: 908¿915. DOI: 10.3109/01443615.2013.823925. A (B)(6) CHINESE WOMAN PRESENTED WITH A 1-YEAR HISTORY OF LEAKING URINE ON EXERTION WHICH WAS UNRESOLVED AFTER PELVIC FLOOR EXERCISES. FURTHER EXAMINATION REVEALED URODYNAMIC STRESS INCONTINENCE WITH ABSENCE OF ABNORMAL DETRUSOR ACTIVITY. THE PATIENT UNDERWENT TVT-O (ETHICON) DAY-CASE PROCEDURE UNDER GENERAL ANESTHESIA. TWO HOURS FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF SEVERE VULVAL PAIN AND A LARGE TENSE HEMATOMA IN THE UPPER-THIRD OF LEFT LABIUM MAJUS WHICH REQUIRED FURTHER EVACUATION UNDER GENERAL ANESTHESIA TO MINIMIZE THE RISK OF INFECTION AND TO REDUCE PAIN. BRISK BLEEDING WAS NOTED FROM UNDER THE LOWER BORDER OF THE INFERIOR PUBIC RAMUS AT THE BASE OF THE CAVITY WHICH WAS SUSPECTED TO BE AN ARTERIAL BLEEDING WHICH WAS TREATED WITH A MICROCATHETER AND SERIES OF COILS WERE PLACED ABOVE AND BELOW THE BLEEDING POINT. HEMOSTASIS WAS CONFIRMED ON THE SUBSEQUENT ANGIOGRAM. FURTHER TREATMENT INCLUDED BLOOD TRANSFUSION AND ANTIBIOTIC PROPHYLAXIS. ON SUBSEQUENT FOLLOW-UPS, THE VULVA HEALED WELL AND THE PATIENT REPORTED NO SIGNS OF STRESS URINARY INCONTINENCE, BLADDER OVERACTIVITY, OR VOIDING DYSFUNCTION SINCE THE OPERATION. THE AUTHORS BELIEVED THAT THIS IS THE FIRST CASE REPORTING AN ARTERIAL HEMORRHAGE FOLLOWING TVT-O INSERTION, AND DEMONSTRATES THAT SERIOUS HEMORRHAGIC COMPLICATIONS ARE NOT ENTIRELY ELIMINATED BY AVOIDING THE RETROPUBIC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884378 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention