BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8065044 · Received November 13, 2018

    Report

    Report Number
    2210968-2018-77125
    Event Type
    Injury
    Date Received
    November 13, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. CITATION: J ROBOTIC SURG (2018) 12:295¿301; DOI: HTTPS://DOI.ORG/10.1007/S11701-017-0726-9.

    Additional Manufacturer Narrative · 1

    PC-(B)(4) DATE SENT TO THE FDA: (B)(4) 2018 CORRECTED PATIENT CODES: (B)(6) ¿ SURGICAL INTERVENTION 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 PRODUCTS (MERSILENE TAPE) 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 PRODUCTS USED IN THIS PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: MINIMALLY INVASIVE ABDOMINAL CERCLAGE COMPARED TO LAPAROTOMY: A COMPARISON OF SURGICAL AND OBSTETRIC OUTCOMES" AUTHOR(S): SOORIN KIM, AMANDA HILL, GULDEN MENDERES, SARAH CROSS, MASOUD AZODI, MERT OZAN BAHTIYAR. CITATION: J ROBOTIC SURG (2018) 12:295¿301; DOI: HTTPS://DOI.ORG/10.1007/S11701-017-0726-9. THE OBJECTIVE OF THIS RETROSPECTIVE COHORT WAS TO REPORT SURGICAL AND OBSTETRIC OUTCOMES OF PATENTS FOLLOWING ABDOMINAL CERCLAGE PLACEMENT THROUGH EITHER MINIMALLY INVASIVE (MIS) OR OPEN TECHNIQUE. BETWEEN DEC2011 AND DEC2015, 11 FEMALE PATIENTS (AGE OF 34±4.26 YEARS) UNDERWENT MIS ABDOMINAL CERCLAGES AND 9 FEMALE PATIENTS (AGE OF 34.44±3.77 YEARS) UNDERWENT OPEN CERCLAGE. ON BOTH TECHNIQUES, MERSELENE TAPE WAS FED THROUGH THE WINDOWS AND TIED ANTERIORLY AND THE BLADDER PERITONEUM WAS CLOSED OVER THE MERSELENE KNOT. THERE WAS ONE PATIENT WHO EXPERIENCED MILD INTRAOPERATIVE VAGINAL BLEEDING DURING ROBOTIC-ASSISTED CERCLAGE AND WAS OBSERVED OVERNIGHT. BLEEDING CEASED AND THE FETUS REMAINED VIABLE. ANOTHER PATIENT REQUIRED REMOVAL OF THE CERCLAGE WHICH HAD BEEN PLACED AT THE TIME OF ROBOTIC TRACHELECTOMY, DUE TO EROSION. MIS ABDOMINAL CERCLAGE IS A SAFE ALTERNATIVE WHEN PERFORMED BY A SURGEON WITH APPROPRIATE TRAINING AND TECHNICAL SKILLS, AND OBSTETRIC OUTCOMES ARE COMPARABLE TO THOSE AFTER OPEN ABDOMINAL CERCLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906037 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention