BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 10826264 · Received November 11, 2020

    Report

    Report Number
    2210968-2020-08977
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    November 29, 2019
    Report Date
    October 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 12/3/2020. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE, SILK SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (INCISION DEHISCENCE, OBSTRUCTION OF THE DRAINAGE TUBE, INCISIONAL SITE INFECTIONS) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL SUTURE, SILK SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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 SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 ETHICON PRODUCT (VICRYL SUTURE, SILK SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (INCISION DEHISCENCE, OBSTRUCTION OF THE DRAINAGE TUBE, INCISIONAL SITE INFECTIONS) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL SUTURE, SILK SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ABOVE. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: TRANSL CANCER RES 2020;9(2):910-917. DOI: HTTP://DX.DOI.ORG/10.21037/TCR.2019.12.32. NOTE: EVENTS REPORTED VIA MW# 2210968-2020-08978.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MODIFIED SUBCUTANEOUS SUCTION DRAINAGE TO PREVENT INCISIONAL SURGICAL SITE INFECTIONS AFTER RADICAL COLORECTAL SURGERY" AUTHOR: JINFU ZHUANG, WEI ZHENG, SHUGANG YANG, JIANXIN YE. CITATION: TRANSL CANCER RES 2020;9(2):910-917. DOI: HTTP://DX.DOI.ORG/10.21037/TCR.2019.12.32. THE STUDY AIMS TO EVALUATE THIS NEW METHOD (SUBCUTANEOUS SUCTION DRAINAGE AND INTERMITTENT IRRIGATION) IN PATIENTS WHO UNDERWENT RADICAL COLORECTAL SURGERY. FROM APRIL 2015 TO NOVEMBER 2017, A TOTAL OF 119 PATIENTS WHO UNDERWENT OPEN RADICAL COLORECTAL SURGERY WERE INCLUDED IN THIS STUDY. A TOTAL OF 61 PATIENTS WERE INCLUDED IN THE IRRIGATION GROUP WHO HAD SUBCUTANEOUS SUCTION DRAINAGE OR INTERMITTENT IRRIGATION (MEAN AGE: 58.2±10.6, MALE N=32, FEMALE N=26, MEAN BMI: 23.7±2.65), AND 58 PATIENTS WERE INCLUDED IN THE CONTROL GROUP WITH NO SUBCUTANEOUS SUCTION DRAINAGE AND INTERMITTENT IRRIGATION (MEAN AGE: 60.3±11, MALE N=33, FEMALE N=28, MEAN BMI: 24.0±2.53, AND). THE 1-VICRYL (ETHICON) WAS USED TO SUTURE THE LINEA, AND THE 3-0 MERSILK (ETHICON) WAS USED TO SUTURE THE SKIN AND SUBCUTANEOUS FAT. SALINE WAS ROUTINELY PERFORMED FOR PROPHYLACTIC WOUND IRRIGATION AFTER LINEA ALBA CLOSURE. SUBCUTANEOUS SUCTION DRAINAGE AND IRRIGATION TUBES WERE INSERTED IN THE IRRIGATION GROUP. IN THE IRRIGATION GROUP, POST-OPERATIVE COMPLICATIONS INCLUDED THE PATIENT WHO COUGHED REPEATEDLY WHICH LED TO INCISION DEHISCENCE (N=1) AND UNDERWENT A SECOND SURGERY, OBSTRUCTION OF THE DRAINAGE TUBE (UNABLE TO WASH) (N=2) IN WHICH ONE OF THE PATIENT HAD A LOCAL INFECTION OF THE INCISION (N=1). THE IRRIGATION TUBE WAS REMOVED, AND THE DRAINAGE TUBE WAS KEPT. INCISIONAL SITE INFECTIONS (SUPERFICIAL N=3, DEEP N=2 AND INCISIONAL N=5) WERE ALSO REPORTED. FOR THE CONTROL GROUP, INCISION DEHISCENCE (N=3) AND INCISIONAL SITE INFECTIONS (SUPERFICIAL N=15, DEEP N=7 AND INCISIONAL N=22) WERE REPORTED POSTOPERATIVELY AND ALL OF PATIENTS WITH INCISION DEHISCENCE ACCEPTED THE SECONDARY SURGERY. THE SUBCUTANEOUS SUCTION DRAINAGE AND INTERMITTENT IRRIGATION IS SAFE AND EFFECTIVE TO PREVENT INCISIONAL SSIS IN RADICAL COLORECTAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287995 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention