BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8090573 · Received November 20, 2018

    Report

    Report Number
    2210968-2018-77251
    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 Location
    NV, 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: ULTRASOUND OBSTET GYNECOL. 2010; 36: 482¿485. DOI: 10.1002/UOG.7675. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "CLINICAL IMPLICATION OF INTRA-AMNIOTIC SLUDGE ON ULTRASOUND IN PATIENTS WITH CERVICAL CERCLAGE." AUTHORS: L. A. GORSKI, W. H. HUANG, B. K. IRIYE AND J. HANCOCK. CITATION: ULTRASOUND OBSTET GYNECOL. 2010; 36: 482¿485. DOI: 10.1002/UOG.7675. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER INTRA-AMNIOTIC (IA) SLUDGE, A SONOGRAPHIC FINDING OF HYPERECHOIC MATTER IN THE AMNIOTIC FLUID CLOSE TO THE INTERNAL CERVICAL OS, IS ASSOCIATED WITH PRETERM DELIVERY IN PATIENTS WITH CERVICAL CERCLAGE. A RETROSPECTIVE COHORT STUDY OF 177 PATIENTS WHO UNDERWENT MCDONALD CERCLAGE BETWEEN JANUARY 1997 AND DECEMBER 2004 WAS CONDUCTED, OF WHICH, 60 PATIENTS (MATERNAL AGE: 30.8 ± 5.4) HAD SONOGRAPHIC EVIDENCE OF IA SLUDGE (GROUP 1) AND 117 PATIENTS (MATERNAL AGE: 29.6 ± 5.2) HAD ABSENCE OF IA SLUDGE (GROUP 2). DURING THE SURGICAL PROCEDURE, CERCLAGE WAS PLACED WITH A SINGLE MERSILENE 5-MM TAPE (ETHICON) UTILIZING THE MCDONALD TECHNIQUE. IN BOTH GROUPS, REPORTED COMPLICATIONS INCLUDED VAGINAL BLEEDING (N-29; GROUP 1: N-10 AND GROUP 2: N-19), PRETERM PREMATURE RUPTURE OF MEMBRANES (N-6; GROUP 1: N-5 AND GROUP 2: N-1), AND CHORIOAMNIONITIS (N-3; GROUP 1: N-2 AND GROUP 2: N-1). IT WAS REPORTED THAT IA SLUDGE ON ULTRASOUND IS NOT ASSOCIATED WITH AN INCREASED RISK OF PRETERM DELIVERY IN PATIENTS WITH CERVICAL CERCLAGE. THE AUTHORS SHOULD EXERCISE CAUTION WHEN TREATING PATIENTS WITH THE SONOGRAPHIC FINDING OF IA SLUDGE AND MAINTAIN THE SAME LEVEL OF VIGILANCE AS FOR ANY PATIENT WITH AN INCREASED RISK FOR PRETERM LABOR AND DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931212 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention