BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    MDR report key: 7929678 · Received October 3, 2018

    Report

    Report Number
    2210968-2018-76253
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    September 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE 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 ¿ EXACT) 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: INT UROGYNECOL J (2015) 26:303¿305; DOI 10.1007/S00192-014-2494-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: BLEEDING COMPLICATION WITH THE TVT-EXACT PROCEDURE: A REPORT OF TWO CASES. THIS STUDY AIMED TO PRESENT TWO CASES OF BLEEDING FOLLOWING USE OF TENSION-FREE VAGINAL TAPES (TVT)-EXACT SYSTEM. THE FIRST CASE WAS AN 81-YEAR-OLD FEMALE PATIENT WITH STRESS URINARY INCONTINENCE (SUI) TREATED WITH RETROPUBIC TENSION-FREE VAGINAL TAPE USING TVT-EXACT SYSTEM. FOUR HOURS, AFTER REMOVAL OF VAGINAL PACK, SHE EXPERIENCED SEVERE BLEEDING FROM THE RIGHT SUPRAPUBIC INCISION AND ULTRASOUND REVEALED BLOOD CLOT IN THE SPACE OF RETZIUS 5X6X5CM. BLEEDING CEASED AFTER REINSERTION OF VAGINAL PACKING. THREE MONTHS AFTER SURGERY THE HEMATOMA WAS COMPLETELY RESOLVED, AND THE PATIENT WAS CONTINENT. THE SECOND CASE WAS A 53-YEAR-OLD FEMALE PATIENT WITH RECURRENT SUI WHO UNDERWENT RETROPUBIC TAPE PROCEDURE USING TVT-EXACT SYSTEM. TWELVE HOURS LATER, SHE COMPLAINED OF PAIN IN THE LOWER ABDOMINAL REGION, NEAR THE LEFT INCISION AFTER TAPE INSERTION TREATED WITH PAIN KILLERS, BUT STILL COMPLAINED OF INCREASE OF PAIN. VISIBLE HEMATOMA AND BLEEDING (INCISION) WERE OBSERVED AND ULTRASOUND REVEALED HYPOECHOGENIC MASS OF 8 CM IN DIAMETER IN THE SPACE OF RETZIUS. THE PATIENT WAS TREATED WITH VAGINAL PACKING, BUT HEMATOMA INCREASE IN SIZE TO 12CM. SURGICAL REVISION OF THE SPACE OF RETZIUS WAS PERFORMED TO WHICH BLEEDING WAS LOCALIZED FROM THE VESSEL BEYOND THE TAPE ON THE POSTERIOR PART OF THE PUBIC BONE AND WAS TREATED WITH BIPOLAR COAGULATION. SOME MINOR BLEEDING PERSISTED, AND AFTERWARD THE BONE WAS COVERED WITH ABSORBABLE HEMOSTAT (SURGICEL). THE HEMOGLOBIN LEVEL DROPPED TO 64 G/L FROM A PRE-OPERATIVE 130 G/L, AND THE PATIENT WAS GIVEN A BLOOD TRANSFUSION. THE FURTHER POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED ON THE 5TH DAY WITH A HEMOGLOBIN LEVEL OF 99 G/L. THE CASES PRESENTED HERE THUS DEMONSTRATE THAT BLEEDING COMPLICATIONS CAN OCCUR WITH USE OF THE TVT-EXACT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772494 TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention