BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 12586560 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09294
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    June 16, 2020
    Report Date
    October 6, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 G/M VICRYL CE. (B)(4). DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED: DERMABOND ADVANCED, VICRYL PLUS SUTURE AND PDS PLUS SUTURE, CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS OF: SURGICAL SITE INFECTION, DEEP SURGICAL SITE INFECTIONS, ORGAN/SPACE LEVEL INFECTIONS, POSTOPERATIVE PAIN DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS: DERMABOND ADVANCED, VICRYL PLUS SUTURE AND PDS PLUS SUTURE, USED IN THIS PROCEDURE? 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. CITATION: ANNALS OF SURGICAL TREATMENT AND RESEARCH HTTPS://DOI.ORG/10.4174/ASTR.2020.99.3.146. NOTE: EVENTS REPORTED ON MW# 2210968-2021-09292, MW# 2210968-2021-09293.

    Description of Event or Problem · 0

    TITLE: SURGICAL SKIN ADHESIVE BOND IS SAFE AND FEASIBLE WOUND CLOSURE METHOD TO REDUCE SURGICAL SITE INFECTION FOLLOWING MINIMALLY INVASIVE COLORECTAL CANCER SURGERY AUTHOR/S: CHUL SEUNG LEE, SEUNG-RIM HAN, BONG-HYEON KYE, JUNG HOON BAE, WOOREE KOH, IN KYU LEE, DO-SANG LEE, YOON SUK LEE CITATION: ANNALS OF SURGICAL TREATMENT AND RESEARCH. HTTPS://DOI.ORG/10.4174/ASTR.2020.99.3.146. THE OBJECTIVE OF THIS STUDY WAS TO COMPARATIVELY EVALUATE THE ROLE OF SURGICAL SKIN ADHESIVES WITH THAT OF SKIN STAPLING IN REDUCING THE RATE OF SURGICAL SITE INFECTIONS (SSIS) FOLLOWING MINIMALLY INVASIVE SURGICAL (MIS) TECHNIQUE FOR COLORECTAL CANCER SURGERY. BETWEEN JANUARY 2017 AND FEBRUARY 2019, A TOTAL OF 492 PATIENTS WHO UNDERWENT MIS (ROBOTIC OR LAPAROSCOPIC COLORECTAL SURGERY) FOR CLINICAL TNM STAGE I¿IV COLORECTAL CANCER WITH SURGICAL ADHESIVE CLOSURE USED IN 284 (57.7%, GROUP I) AND SKIN STAPLING IN 208 PATIENTS (42.3%, GROUP II) WERE INCLUDED IN THE STUDY. FROM JANUARY 2017 TO MAY 2018, SURGEONS HAVE USED ONLY SKIN STAPLER (VISISTAT SKIN STAPLER, TELEFLEX, WAYNE, PA, USA) FOR SURGICAL WOUND CLOSURE. FROM AUGUST 2018 TO FEBRUARY 2019, SURGEONS HAVE USED ONLY SURGICAL SKIN ADHESIVE BOND (DERMABOND ADVANCED TOPICAL SKIN ADHESIVE, ETHICON, CINCINNATI, OH, USA). THERE WERE NO DIFFERENCES IN PATIENTS' CHARACTERISTICS BETWEEN THE 2 GROUPS, INCLUDING PATIENT-RELATED FACTORS, SYSTEMIC INFLAMMATION FACTORS AND NUTRITIONAL STATUS. THE MEAN AGES OF PATIENTS IN GROUP I AND GROUP II WERE 63.6 ± 12.7 YEARS AND 64.4 ± 12.8 YEARS, RESPECTIVELY. THE MEAN BMI IN GROUP I AND GROUP II WAS 23.4 ± 3.9 KG/M2 AND 23.8 ± 3.0 KG/M2, RESPECTIVELY. THE DISTRIBUTION OF LOCATION OF THE CANCER WAS ALSO NOT DIFFERENT BETWEEN THE GROUPS. THE ROBOTIC APPROACH WAS MORE IN GROUP I (55 CASES VS. 5 CASES, P < 0.001). AFTER COLON OR RECTAL RESECTION USING A LAPAROSCOPE OR ROBOT, EXTENSION OF THE UMBILICAL INCISION WITHIN 5.0¿7.0-CM LONG WAS PERFORMED FOR REMOVAL OF THE SPECIMEN THROUGH THE WOUND PROTECTOR (SURGITRACTOR, SURGICORE, GWANGJU, KOREA). AN EXTRACORPOREAL ANASTOMOSIS WAS PREFERRED FOR RIGHT-SIDED COLON CANCERS AND AN INTRACORPOREAL ANASTOMOSIS FOR LEFT-SIDED COLON CANCERS. THE DAVINCI XI SURGICAL SYSTEM (INTUITIVE SURGICAL, SUNNYVALE, CA, USA) WAS USED FOR ALL ROBOT-ASSISTED PROCEDURES. ANTIBIOTIC-COATED SUTURES (COATED VICRYL PLUS ANTIBACTERIAL [POLYGLACTIN 910] SUTURE, PDS PLUS ANTIBACTERIAL [POLYDIOXANONE] SUTURE; ETHICON) WERE USED FOR CLOSURE OF THE FASCIA AND SUBCUTANEOUS LAYERS IN BOTH GROUPS. IN SURGICAL SKIN ADHESIVE GROUP, SKIN BOND WAS APPLIED AFTER SUBCUTICULAR LAYER WAS APPROXIMATED USING 4-0 VICRYL SUTURES. WHEN USING A SKIN STAPLER, SKIN STAPLER WAS APPLIED JUST AFTER SUBCUTANEOUS SUTURE. SURGICAL WOUND DRESSING WAS PERFORMED AT POSTOPERATIVE 1ST, 2ND, AND 4TH DAY IN SURGICAL SKIN STAPLER GROUP AND SKIN STAPLERS WERE REMOVED AT POSTOPERATIVE 7TH TO 10TH DAYS AT OUTPATIENT'S CLINIC. ROUTINE SURGICAL WOUND DRESSING WAS NOT PERFORMED IN SURGICAL SKIN ADHESIVE GROUP. WITH REGARD TO PERIOPERATIVE OUTCOMES (TABLE 2), THE ESTIMATED INTRAOPERATIVE BLOOD LOSS AND RATE OF INTRAOPERATIVE TRANSFUSION WERE NOT DIFFERENT BETWEEN THE GROUPS. THE OPERATIVE TIME WAS SIGNIFICANTLY LONGER IN GROUP I (222.5 ± 72.2 MINUTES) THAN IN GROUP II (145.4 ± 63.8 MINUTES) (P < 0.01). REPORTED COMPLICATIONS INCLUDED N=15 SURGICAL SITE INFECTION, N=2 DEEP SURGICAL SITE INFECTIONS, N=? POSTOPERATIVE PAIN AND N=10 ORGAN/SPACE LEVEL INFECTION. IN CONCLUSION, THIS STUDY SHOWED THAT SURGICAL SKIN ADHESIVE BOND REDUCED SURGICAL SITE INFECTION AND TOTAL COST FOR WOUND CARE FOLLOWING MINIMALLY INVASIVE COLORECTAL CANCER SURGERY COMPARED TO CONVENTIONAL SKIN STAPLER TECHNIQUE. SURGICAL SKIN ADHESIVE BOND IS A SAFE AND FEASIBLE ALTERNATIVE SURGICAL WOUND CLOSURE TECHNIQUE FOLLOWING MINIMALLY INVASIVE COLORECTAL CANCER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481917 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention