BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8119584 · Received November 30, 2018

    Report

    Report Number
    2210968-2018-77423
    Event Type
    Injury
    Date Received
    November 30, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: JOURNAL OF PERINATOLOGY (2009) 29, 276¿279; DOI:10.1038/JP.2008.221 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : PREGNANCY OUTCOME AFTER PLACEMENT OF ¿RESCUE¿ SHIRODKAR CERCLAGE" AUTHOR : G VENTOLINI, TJ GENRICH, J ROTH AND R NEIGER CITATION: JOURNAL OF PERINATOLOGY (2009) 29, 276¿279; DOI:10.1038/JP.2008.221 THE PURPOSE OF THIS RETROSPECTIVE COHORT STUDY WAS TO EVALUATE THE PREGNANCY OUTCOME OF WOMEN WHO PRESENTED WITH ADVANCED MID-TRIMESTER CERVICAL DILATION AND BULGING AMNIOTIC MEMBRANES WHO ELECTED TO UNDERGO PLACEMENT OF SHIRODKAR CERVICAL CERCLAGE COMPARED WITH A SMALL GROUP OF PATIENTS WHO OPTED FOR EXPECTANT MANAGEMENT. BETWEEN 2JAN2003 AND 31DEC2005, 56 FEMALE PATIENTS (AVERAGE MATERNAL AGE OF 26.4±8.3 YEARS) WITH LATE MID-TRIMESTER CERVICAL DILATATION WHO UNDERWENT PLACEMENT OF SHIRODKAR CERCLAGE. IN THE CERCLAGE PROCEDURE, A 5MM MERSILENE TAPE WAS USED. FOLLOWING THE PLACEMENT OF THE CERCLAGE, 8 PATIENTS EXPERIENCED PREMATURE RUPTURE OF MEMBRANES AND ONE OF THEM OCCURRED DURING THE CERCLAGE PROCEDURE. ANOTHER PATIENT EXPERIENCED EXCESSIVE BLEEDING DURING PLACEMENT OF CERCLAGE WHICH REQUIRED SUTURING OF THE CERVIX. FURTHERMORE, ONE PATIENT DEVELOPED SEPSIS WHICH REQUIRED ADMISSION TO INTENSIVE CARE UNIT AND EXPERIENCED FETAL DEMISE AT (B)(6) GESTATION. THE AUTHORS SUGGESTED THAT THERE WAS NO CORRELATION BETWEEN THE LENGTH OF THE CERVIX BELOW THE LEVEL OF CERCLAGE AND GESTATIONAL AGE AT DELIVERY. WHEN PREGNANCIES ARE COMPLICATED BY LATE MID-TRIMESTER CERVICAL DILATION, PLACEMENT OF SHIRODKAR CERCLAGE IN APPROPRIATELY SELECTED PATIENTS HAS THE POTENTIAL TO BE A BENEFICIAL THERAPEUTIC OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960782 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention