BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8107389 · Received November 27, 2018

    Report

    Report Number
    2210968-2018-77351
    Event Type
    Injury
    Date Received
    November 27, 2018
    Report Date
    November 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: THE JOURNAL OF MATERNAL-FETAL AND NEONATAL MEDICINE, 2012; 25(9): 1779¿1782; DOI: 10.3109/14767058.2012.663830 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : EFFECT OF CERCLAGE ON LABOR COURSE AND OBSTETRIC OUTCOME: A CASE-CONTROL STUDY" AUTHOR : JAE EUN SHIN, JONG CHUL SHIN, SA JIN KIM & YOUNG LEE CITATION: THE JOURNAL OF MATERNAL-FETAL AND NEONATAL MEDICINE, 2012; 25(9): 1779¿1782; DOI: 10.3109/14767058.2012.663830 THE OBJECTIVE OF THIS RETROSPECTIVE CASE-CONTROL STUDY WAS TO EVALUATE THE EFFECTS OF CERCLAGE ON LABOR COURSE AND OBSTETRIC COMPLICATIONS, AND TO DETERMINE WHETHER THERE IS AN ASSOCIATION BETWEEN CERCLAGE AND CESAREAN DELIVERY RATE. FROM 1994 TO 2009, A TOTAL OF 127 FEMALE PATIENTS (MEAN ± SD AGE OF 31.0±4.0 YEARS) UNDERWENT CERVICAL CERCLAGE WHICH WERE MATCHED IN CONTROL GROUP COMPRISING 254 FEMALE PATIENTS (MEAN ± SD AGE OF 32.8±3.8 YEARS). ALL CERCLAGE WERE PERFORMED USING MCDONALD TECHNIQUE AND THE SUTURE WAS MADE USING MERSILENE TAPE. DYSFUNCTIONAL LABOR AND PERINATAL OUTCOMES INCLUDED PROLONGED LATENT PHASE, ARREST OF DILATATION, CERVICAL LACERATION (N=12) REQUIRING SURGICAL REPAIR, AND POSTPARTUM HEMORRHAGE (N=3) FOR WHICH ONE PATIENT RECOVERED AFTER CONSERVATIVE TREATMENT AND TWO PATIENTS HAD TO UNDERGO EMERGENCY HYSTERECTOMY FOR BLEEDING DUE TO UTERINE RUPTURE AND DEEP CERVICAL LACERATIONS THAT EXTENDED TO THE LOWER UTERINE SEGMENT AND COULD NOT BE SUTURED SUFFICIENTLY BY THE VAGINAL APPROACH. IN THIS STUDY, CERCLAGE WAS ASSOCIATED WITH AN INCREASED INCIDENCE OF A PROLONGED LATENT PHASE, BUT NOT WITH AN INCREASED TOTAL DURATION OF LABOR OR AN INCREASED RATE OF CESAREAN DELIVERIES. CERCLAGE MAY AFFECT CERVICAL EFFACEMENT, BUT ONCE SOFTENING IS ACHIEVED, LABOR APPEARS TO PROGRESS IN THE NORMAL WAY. CERCLAGE MAY AFFECT THE PROCESSES INVOLVED IN THE DEGRADATION OF COLLAGEN, LEADING TO A PROLONGED LATENT PHASE BY CERVICAL SCARRING. A POSSIBLE REASON FOR CERVICAL LACERATION IN CERCLAGE WAS THAT THE FOREIGN BODY REACTION AROUND THE CERVICAL STITCH AND THE RESULTING SCAR TISSUE MAKE THE CERVIX MORE SUSCEPTIBLE TO INJURY DURING DELIVERY. ANOTHER POSSIBLE EXPLANATION IS THAT THE INSUFFICIENT CERVIX WAS INTRINSICALLY MORE PRONE TO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948138 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE NEEDLE, CERCLAGE, GYNECOLOGICAL KDC ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention