BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 7694427 · Received July 17, 2018

    Report

    Report Number
    2210968-2018-74436
    Event Type
    Death
    Date Received
    July 17, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON SUTURE CAUSED/ CONTRIBUTED TO THE NEONATAL DEATH (DUE TO PREMATURITY AND SEPSIS)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: AUS. NZ J OBSTET GYNAECOL 1997: 37: 4:407-411. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: TREATMENT OF CERVICAL INCOMPETENCE BY TRANSABDOMINAL CERVICOISTHMIC CERCLAGE" AUTHOR(S): SIMON CRAIG, MBSS AND JOHN R.H. FLIEGER, MD 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 2, A (B)(6) PREGNANT WOMAN HAD TCC INSERTION EXPERIENCED SPONTANEOUS RUPTURE OF MEMBRANE WITH CHORIOAMNIONITIS AT (B)(6) FOR WHICH HYSTEROTOMY WAS PERFORMED. TWELVE MONTHS LATER, THE PATIENT CONCEIVED AND HAD SPONTANEOUS RUPTURE OF MEMBRANE WITH PRESUMED CHORIOAMNIONITIS AT (B)(6) WHICH SHE UNDERWENT CAESARIAN SECTION AND HAD NEONATAL DEATH RESULTED DUE TO PREMATURITY AND SEPSIS. TWO YEARS LATER, THIS PATIENT HAD ONGOING PELVIC PAIN FOR WHICH TCC WAS REMOVED. 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
    536825 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death