BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 8224337 · Received January 7, 2019

    Report

    Report Number
    2210968-2019-78249
    Event Type
    Injury
    Date Received
    January 7, 2019
    Report Date
    December 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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: INTERNATIONAL JOURNAL OF GYNECOLOGY AND OBSTETRICS (2007) 96, 16¿19; DOI:10.1016/J.IJGO.2006.09.002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: FAVORABLE OUTCOME FOLLOWING EMERGENCY SECOND TRIMESTER CERCLAGE". AUTHORS: A. DEBBY, O. SADAN, M. GLEZERMAN, A. GOLAN. CITATION: INTERNATIONAL JOURNAL OF GYNECOLOGY AND OBSTETRICS (2007) 96, 16¿19; DOI:10.1016/J.IJGO.2006.09.002. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE RESULTS OF PREGNANCY AND NEONATAL OUTCOME OF CERVICAL CERCLAGE PERFORMED DURING THE SECOND TRIMESTER OF PREGNANCY IN DIFFERENT EMERGENCY SITUATIONS: WITH BULGING OF MEMBRANES AND WITHOUT. DURING THE 15 YEARS PERIOD, BETWEEN 1990 AND 2005, 99 PATIENTS UNDERWENT AN EMERGENCY SECOND TRIMESTER CERCLAGE AND WERE DIVIDED INTO TWO GROUPS: ALL PATIENTS PRESENTED WITH CERVICAL EFFACEMENT AND DILATION WITHOUT BULGING OF MEMBRANES INTO THE VAGINA (GROUP 1; N=75) AND ALL PATIENTS HAD A DILATED AND EFFACED CERVIX WITH BULGING OF MEMBRANES INTO THE VAGINA IN AN HOURGLASS FORMATION (GROUP 2; N=24). IN BOTH GROUPS, THE CERVICAL SUTURE WAS PLACED IN THE MCDONALD METHOD USING DOUBLE SILK NO 4 (MERSILK, ETHICON, JOHNSON AND JOHNSON, U.S.A) IN THE FIRST 8 YEARS OF THE STUDY AND THEN REPLACED BY MERCILEN SUTURE. COMPLICATION OF THE PROCEDURE INCLUDED PREMATURE CONTRACTIONS (N=19), ABRUPTIO PLACENTA (N=5), REPEAT CERCLAGE (N=6), PRETERM PREMATURE RUPTURE OF MEMBRANES (N=20) AND CHORIOAMNIONITIS (N=17). THE RESULTS OF THE PRESENT STUDY DEMONSTRATED A FAVORABLE PROLONGATION OF PREGNANCY AND NEONATAL OUTCOME IN EMERGENCY SECOND TRIMESTER CERCLAGE EVEN WHEN BULGING OF THE MEMBRANES EXISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15754 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention