BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 12506247 · Received September 21, 2021

    Report

    Report Number
    2210968-2021-08686
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    December 22, 2020
    Report Date
    September 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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 ANY OF THE 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 ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2021-08689. CITATION: INTERNATIONAL SURGERY JOURNAL, KAUR A ET AL. INT SURG J. 2021 JAN;8(1):103-110, HTTP://WWW.IJSURGERY.COM; DOI: HTTPS://DX.DOI.ORG/10.18203/2349-2902.ISJ20205820.

    Description of Event or Problem · 1

    TITLE: TRICLOSAN COATED VICRYL VERSUS UNCOATED VICRYL IN PREVENTING SURGICAL SITE INFECTION: A RANDOMIZED CONTROLLED TRIAL. THE MAIN OBJECTIVE OF THE STUDY WAS TO COMPARE THE INCIDENCE OF SURGICAL SITE INFECTION AFTER WOUND CLOSURE WITH TRICLOSAN COATED VICRYL (VICRYL PLUS) VERSUS UNCOATED VICRYL. IN THIS STUDY, 100 CASES WERE SELECTED WHO WERE ADMITTED IN SRI GURU RAM DAS INSTITUTE OF HEALTH SCIENCES AND RESEARCH, VALLAH, AMRITSAR FROM SEPTEMBER 2018 TO SEPTEMBER 2020. PROPHYLACTIC ANTIBIOTICS WERE GIVEN TO ALL THE PATIENTS ONE HOUR BEFORE THE ONSET OF THE SURGERY. IN GROUP A PATIENTS, WOUNDS WERE CLOSED SUBCUTANEOUSLY AND INTRACUTANEOUSLY WITH A MULTIFILAMENT POLYGLACTIN 910 SUTURE COATED WITH TRICLOSAN (VICRYL PLUS, JOHNSON AND JOHNSON, PVT. LTD.). WHILE THE WOUNDS OF THE PATIENTS IN GROUP B WERE CLOSED SUBCUTANEOUSLY AND INTRACUTANEOUSLY WITH AN UNCOATED MULTIFILAMENT POLYGLACTIN 910 SUTURE (VICRYL, JOHNSON AND JOHNSON, PVT. LTD.). ALL WOUNDS WERE THEN COVERED WITH AN ASEPTIC DRESSING. REPORTED COMPLICATIONS INCLUDED PAIN(N=85), ERYTHEMA (N=74), SWELLING (N=19), FEVER (N=9), WOUND DISCHARGE (N=6), SURGICAL SITE INFECTION (N=11). IN CONCLUSION THUS, WE CONCLUDE FROM OUR OBSERVATIONS THAT TRICLOSAN COATED VICRYL (VICRYL PLUS) IS BETTER THAN UNCOATED VICRYL FOR THE PREVENTION OF SURGICAL SITE INFECTION. THEREFORE, TRICLOSAN COATED VICRYL (VICRYL PLUS) IS RECOMMENDED OVER UNCOATED VICRYL FOR WOUND CLOSURE IN PATIENTS UNDERGOING ELECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405580 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1