BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8090414 · Received November 20, 2018

    Report

    Report Number
    2210968-2018-77248
    Event Type
    Injury
    Date Received
    November 20, 2018
    Report Date
    November 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    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 PRODUCTS (MERSILENE TAPE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS, INCLUDING FETAL DEMISE, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: OBSTET GYNECOL SCI. 2018; 61(1): 23-29 DOI: HTTPS://DOI.ORG/10.5468/OGS.2018.61.1.23 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: HISTORY-INDICATED CERCLAGE: THE ASSOCIATION BETWEEN PREVIOUS PRETERM HISTORY AND CERCLAGE OUTCOME" AUTHORS:KYONG-NO LEE, EUN-JEE WHANG, KYLIE HAE-JIN CHANG, JI-EUN SONG, GA-HYUN SON, KEUN-YOUNG LEE CITATION: OBSTET GYNECOL SCI. 2018; 61(1): 23-29 DOI: HTTPS://DOI.ORG/10.5468/OGS.2018.61.1.23 IN THIS STUDY, THE AUTHORS AIMED TO EVALUATE THE EFFICACY OF THE REVISED GUIDELINE AND TO INVESTIGATE THE ASSOCIATION BETWEEN PREVIOUS PRETERM HISTORY AND CERCLAGE OUTCOME. THE AUTHORS CONDUCTED A RETROSPECTIVE OBSERVATIONAL STUDY OF 399 CASES OF HISTORY-INDICATED CERCLAGE (HIC) IN SINGLETON PREGNANCIES PERFORMED AT OUR HOSPITAL BETWEEN JANUARY 2007 AND JUNE 2016. THE AUTHORS COMPARED THE PERIOPERATIVE COMPLICATIONS AND INCIDENCES OF PRETERM DELIVERY IN PATIENTS WITH ONE PREVIOUS SECOND-TRIMESTER PREGNANCY LOSS (194 PATIENTS; MATERNAL AGE: 33.2 ± 3.6) AGAINST THOSE IN PATIENTS WITH =2 SECOND-TRIMESTER LOSSES (205 PATIENTS; MATERNAL AGE: 33.7 ± 3.4). DURING THE PROCEDURE IN ALL PATIENTS, CERVICAL CERCLAGES WERE PERFORMED USING THE MCDONALD TECHNIQUE WITH ONE SUTURE USING MERSILENE 5 MM TAPE (ETHICON) PLACED IN A PURSE-STRING FASHION. REPORTED COMPLICATIONS INCLUDED MEMBRANE BULGING (N-16) WHICH REQUIRED REPEAT CERCLAGE, FUNNELING BELOW THE KNOTS (N-4) WHICH REQUIRED REPEAT CERCLAGE, AND PRETERM PREMATURE RUPTURE OF MEMBRANES (N-31). THE COMPARISON OF HIC IN ONE PREVIOUS SECOND-TRIMESTER PREGNANCY LOSS GROUP WITH HIC IN THE 2 OR MORE PREVIOUS SECOND TRIMESTER PREGNANCY LOSS GROUP FOUND NO DIFFERENCE IN PREGNANCY OUTCOME. THIS FINDING SUPPORTS THE AMENDED ACOG GUIDELINE FOR HIC INDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932229 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention