BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 7034718 · Received November 15, 2017

    Report

    Report Number
    2210968-2017-71251
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    February 6, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, J CLIN GYNECOL OBSTET. 2017; DOI: HTTPS://DOI.ORG/10.14740/JCGO429W

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-000062689 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? O IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER.? -ES20171690 WAS THIS COMPLAINT PREVIOUSLY REPORTED UNDER ES20171690? IF YES, PLEASE PROVIDE THE PRODUCT COMPLAINT NUMBER. =>WE HAVE NOT CREATED ANOTHER PC FOR THIS ISSUE. ES20171690 WAS REGISTERED IN THE JAPAN SYSTEM FOR PC-000062689. DOES THE SURGEON BELIEVE THAT VICRYL OR VICRYL PLUS SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: SURGICAL SITE INFECTION, ANTIBIOTICS THERAPY? O IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT CODE.? SORRY, WE COULDN'T GET INFORMATION ANY MORE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? -NO. WE COULDN'T GET INFORMATION. O IF YES, PLEASE INCLUDE: ? DATE AND TYPE OF PROCEDURE, ? WHERE PROCEDURE WAS PERFORMED, ? SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, ? PRODUCT INVOLVED? PRE-EXISTING CONDITIONS.? ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR VICRYL AND VICRYL PLUS SUTURES?-NO.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE "CAN TRICLOSAN-COATED SUTURES AND THE USE OF DOUBLE GLOVES REDUCE THE INCIDENCE OF SURGICAL SITE INFECTIONS?¿ THAT ABDOMINAL HYSTERECTOMY WAS PERFORMED WITH DOUBLE GLOVING AND COATED SUTURE WAS USED ON THE VAGINA STUMP IN THE SECOND GROUP. THE AUTHORS INVESTIGATED WHETHER SUTURE COUPLED WITH DOUBLE GLOVING COULD REDUCE INCIDENCE OF SSIS FOLLOWING ABDOMINAL HYSTERECTOMY. THE PRIMARY OUTCOME WAS THE INCIDENCE OF SSIS. THE FREQUENCY IN THE SECOND GROUP REQUIRING POSTOPERATIVE ANTIBIOTIC THERAPY WAS SIGNIFICANTLY LESS THAN IN THE FIRST GROUP. WHEN THE SSIS WERE FURTHER DISTINGUISHED INTO SUPERFICIAL SSIS AND ORGAN SPACE SSIS, THERE WERE ALSO NO STATISTICALLY SIGNIFICANT DIFFERENCES. RE-OPERATION AND DRAINAGE WERE NOT PERFORMED. THE AUTHORS CONCLUDED THAT ¿TRICLOSAN-COATED SUTURES COUPLED WITH DOUBLE GLOVING SHOW POTENTIAL IN THE ABILITY TO REDUCE SSIS AND PREVENT SSIS FROM BECOMING SEVERE.¿ ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813978 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention