BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8028430 · Received November 1, 2018

    Report

    Report Number
    2210968-2018-76871
    Event Type
    Injury
    Date Received
    November 1, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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: AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY (2005) 192, 1989¿94; DOI:10.1016/J.AJOG.2005.02.127. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "TRANSVAGINAL PLACEMENT OF CERVICOISTHMIC CERCLAGE: REPORT ON PREGNANCY OUTCOME." AUTHOR(S): MICHAEL KATZ, MD, CAROL ABRAHAMS, MS. CITATION: AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY (2005) 192, 1989¿94; DOI:10.1016/J.AJOG.2005.02.127. THIS RETROSPECTIVE ANALYSIS WAS CONDUCTED TO DESCRIBE THE PREGNANCY OUTCOME FOR A LARGE NUMBER OF PATIENTS WHO HAD A TRANSVAGINAL CERVICOISTHMIC CERCLAGE. OVER A 10-YEAR PERIOD, FROM 1992 TO 2002, 53 PREGNANT WOMEN UNDERWENT SURGERY FOR TRANSVAGINAL PLACEMENT OF A CERCLAGE AT THE LEVEL OF THE CERVICOISTHMIC JUNCTION BETWEEN 12 AND 17 WEEKS OF GESTATION. IN THE PROCEDURE, A 5-MM MERSILENE TAPE WAS THREADED VERY SUPERFICIALLY, FLAT, THROUGH THE TISSUE AT ANTERIOR SURFACE OF THE CERVICOISTHMIC JUNCTION. ONE PATIENT HAD HER SUTURE REMOVED BECAUSE OF DYSPAREUNIA AND VAGINAL DISCHARGE. PROCEDURE-RELATED COMPLICATION INCLUDED INTRAPARTUM CERVICAL TEAR DUE TO INCOMPLETE REMOVAL BEFORE LABOR (N=1); HEMATOMA (<50ML) BETWEEN BLADDER AND CERVIX (N=1) THAT NEEDED TO BE EVACUATED; AND TRANSIENT URINARY RETENTION WITH PELVIC PAIN (N=2). OTHER POSTOPERATIVE COMPLICATIONS INCLUDED ADMISSION FOR REMOVAL OF POSTCERCLAGE HEMATOMA (N=1); LOWER ABDOMINAL PAIN (N=1); AND CHORIOAMNIONITIS (N=2). THE PLACEMENT OF TRANSVAGINAL CERVICOISTHMIC CERCLAGE WAS ASSOCIATED WITH FAVORABLE PREGNANCY OUTCOME AND MAY BE CONSIDERED AS A SUITABLE SAFE ALTERNATIVE TO THE TRANSABDOMINAL CERCLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868840 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention