BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 10578037 · Received September 23, 2020

    Report

    Report Number
    2210968-2020-07264
    Event Type
    Injury
    Date Received
    September 23, 2020
    Report Date
    September 3, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/16/2020. ADDITIONAL INFORMATION: A2, A3, B7. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (DERMABOND, VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? ANSWER: THE ARTICLE WAS MEANT TO COMPARE THE EFFICACY OF SUTURE CLOSURE TECHNIQUE VERSUS USE OF TISSUE ADHESIVE, IT WAS NOT DIRECTLY INTENDED TO SHOW PRODUCT RELATED COMPLICATIONS. ALTHOUGH AS A SURGEON, WE KNOW THAT EVERY PRODUCT HAS SOME KIND OF COMPLICATION RATES AND THERE ARE PATIENT RELATED FACTORS TOO THAT CAN CONTRIBUTE TO THE COMPLICATIONS. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (DERMABOND, VICRYL SUTURE) USED IN THIS PROCEDURE? ANSWER: WE HAVE BEEN USING ETHICON PRODUCTS, AND INFECTION RATE OR ANY OTHER WOUND RELATED COMPLICATIONS HAVE BEEN ACCEPTABLE AS PER INTERNATIONALLY PUBLISHED DATA. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. ANSWER: NO, THE CASES WERE NOT REPORTED TO ETHICON PRIOR. PATIENT DEMOGRAPHICS VICRYL GROUP: WOUND INFECTION AND WOUND DEHISCENCE: AGE 36 YEARS , DIAGNOSIS : CARCINOMA BREAST. CITATION: MAJEED S, SOOMRO R, KHURSHAIDI N. SKIN ADHESIVE VERSUS ABSORBABLE SUTURE IN CLOSING WOUND. MED FORUM 2018; VOL.29(12):48-51 WEBSITE: WWW.MEDFORUM.PK PLEASE SEE ARTICLE ATTACHED. 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. PATIENTS EVENTS WERE REPORTED VIA 2210968-2020-07263, 2210968-2020-07264, 2210968-2020-08093, 2210968-2020-08095, 2210968-2020-08096 AND 2210968-2020-08097.

    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 ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (DERMABOND, VICRYL SUTURE) 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 (DERMABOND, 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: WOUND. MED FORUM 2018;29(12):48-51 ARTICLE CANNOT BE ATTACHED: OVERSIZED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: SKIN ADHESIVE VERSUS ABSORBABLE SUTURE IN CLOSING WOUND. THIS RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE THE OUTCOMES OF WOUND CLOSURE IN BREAST SURGERY INCISIONS BY CONVENTIONAL SUTURE TECHNIQUE VERSUS TISSUE ADHESIVE. FROM 23MAY2017 TO 31JAN2018, 100 FEMALE PATIENTS WHO UNDERWENT BREAST SURGERY WERE ALLOCATED INTO TWO GROUPS FOR WOUND CLOSURE: GROUP-A (TISSUE ADHESIVE DERMABOND; N=50; MEAN AGE OF 35.72±14.47 YEARS) AND IN GROUP-B (CONVENTIONAL SUTURING TECHNIQUE; N=50; MEAN AGE OF 38.28±13.50 YEARS). IN GROUP A, PATIENTS UNDERWENT SKIN CLOSURE BY TISSUE ADHESIVE DERMABOND (ETHICON INC.). IN GROUP B, PATIENTS UNDERWENT CONVENTIONAL SUBCUTICULAR SUTURING TECHNIQUE WITH 3-0 VICRYL (ETHICON INC.). POSTOPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION (N=2 GROUP A AND N=8 GROUP B), AND WOUND DEHISCENCE (N=1 GROUP A AND N=7 GROUP B). THE STUDY RESULTS SHOWED THAT THE USE OF TISSUE ADHESIVE HAS AN ADVANTAGE WHEN COMPARED TO CONVENTIONAL SUTURING. IN CONCLUSION, OUR STUDY RESULTS SHOWED THAT TISSUE ADHESIVE IS A SAFE AND EFFECTIVE METHOD FOR CLOSURE OF SKIN INCISIONS. THERE IS A SIGNIFICANT DIFFERENCE IN WOUND CLOSURE TIME, WOUND DEHISCENCE AND WOUND INFECTION WHEN COMPARED WITH CONVENTIONAL SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042080 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR