BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9980863 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03254
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS FOR THE (B)(6) YEAR OLD (HEMOSTATIC FAILURE AND ATONIC BLEEDING) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2019) 299:113¿121; DOI:10.1007/S00404-018-4947-6.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MATSUBARA¿YANO SUTURE: A SIMPLE UTERINE COMPRESSION SUTURE FOR POSTPARTUM HEMORRHAGE DURING CESAREAN SECTION". AUTHOR: HIRONORI TAKAHASHI, YOSUKE BABA, RIE USUI, HIROTADA SUZUKI, KENJI HORIE, HITOSHI YANO, AKIHIDE OHKUCHI, SHIGEKI MATSUBARA. CITATION: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2019) 299:113¿121; DOI:10.1007/S00404-018-4947-6. THE AIM OF THIS RETROSPECTIVE OBSERVATIONAL STUDY WAS TO DETERMINE: (I) THE EFFECTIVENESS OF MATSUBARA¿YANO UTERINE COMPRESSION SUTURE (MY) TO ACHIEVE HEMOSTASIS IN THE PRESENCE OF POSTPARTUM HEMORRHAGE (PPH) DURING CESAREAN SECTION (CS), (II) THE TYPE OF PPH FOR WHICH MY IS EFFECTIVE, (III) POST-OPERATIVE COMPLICATIONS OF MY, AND (IV) OUTCOMES OF PREGNANCY AFTER MY. BETWEEN JANUARY 1, 2009 AND DECEMBER 31, 2017, A TOTAL OF 50 PATIENTS (MEDIAN AGE: 35 YEARS, AGE RANGE: 30.5-37.3) WHO HAD MY WERE INCLUDED IN THE STUDY. A 70-MM ROUND NEEDLE WITH NO. 1 COATED VICRYL (ETHICON) TRANSFIXES THE UTERINE CAUDAL PART (LOWER UTERINE BODY) FROM THE ANTERIOR TO POSTERIOR SIDES AND THEN TRANSFIXES THE UTERINE FUNDUS FROM THE POSTERIOR TO ANTERIOR SIDES (LONGITUDINAL SUTURE). COMPLAINTS INCLUDED INTRAUTERINE INFECTION (MYOMETRITIS, AND/OR ENDOMETRITIS) WITH SYMPTOMS OF HIGH-GRADE FEVER, UTERINE TENDERNESS, AND MALODOROUS DISCHARGE (N=3). ALL THREE WERE RESOLVED WITH ANTIBIOTIC ADMINISTRATION. OTHER REPORTED EVENT IS A PATIENT WHO HAD HEMOSTATIC FAILURE AND SHOWED RECURRENT ATONIC BLEEDING (N= (B)(6) YEARS OLD) THREE HOURS AFTER CS. MATSUBARA¿TAKAHASHI (MT) HOLDING WAS INCIDENTALLY DECLAMPED AND THE INTRAUTERINE BALLOON PROLAPSED INTO THE VAGINA, CAUSING THE RECURRENT BLEEDING. IN CONCLUSION, MY SHOWED A HEMOSTATIC EFFECT ON PPH WITHOUT SEVERE POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445927 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention