BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 7681584 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74284
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 04/18/2018.

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: AUS. NZ J OBSTET GYNAECOL 1997: 37: 4:407-411.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: TREATMENT OF CERVICAL INCOMPETENCE BY TRANSABDOMINAL CERVICOISTHMIC CERCLAGE" AUTHOR: SIMON CRAIG, MBBS AND JOHN R.H. FLIENGER, MD, MGO, FRCOG, FRACOG, FRACS CITATION: AUS. NZ J OBSTET GYNAECOL 1997: 37: 4:407-411. THIS STUDY AIMED TO PRESENT FURTHER EVIDENCE THAT TRANSABDOMINAL CERVICOISTHMIC CERCLAGE (TCC) HAS A CONFIRMED ROLE IN OBSTETRIC MANAGEMENT OF A SELECTED SUBGROUP OF WOMEN WITH CERVICAL INCOMPETENCE. BETWEEN 1987 AND 1996, 12 FEMALE PATIENTS (MEAN AGE OF 31 YEARS [RANGED FROM24-38 YEARS]) UNDERWENT TCC. CERCLAGE WAS ACCOMPLISHED USING MERSILINE TAPE (N=10) AND MERSILK (N=2) IN POSTERIOR KNOT (N=4) OR ANTERIOR KNOT (N=8). INSERTION OF THE TCC WAS RELATIVELY UNCOMPLICATED. THERE WERE CASE OF HEAVY BLEEDING DURING TCC. IN CASE 1, A FEMALE PATIENT WHO WAS AT 18 WEEKS GESTATION DEVELOPED CENTRAL PLACENTAL PRAEVIA FOR WHICH PATIENT RECEIVED 2 COURSES OF BETAMETHASONE AFTER 24 WEEKS. AT 34 WEEKS GESTATION, SHE EXPERIENCED PREMATURE RUPTURE OF THE MEMBRANES AND AN EMERGENCY LOWER UTERINE CAESARIAN SECTION WAS PERFORMED. TCC WAS FELT TO BE TIGHTLY IN PLACE AT THE ISTHMUS AND WAS LEFT UNDISTURBED. TRANSABDOMINAL CERVICOISTHMIC CERCLAGE IS A PROCEDURE WITH RISK OF MORBIDITY WHICH SHOULD NOT BE UNDERTAKEN LIGHTLY. HOWEVER IT HAS A DEFINITE PLACE IN THE OBSTETRIC MANAGEMENT OF A SUBGROUP OF WOMEN WITH CERVICAL INCOMPETENCE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525395 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention