BEUDAMED
    FDA Adverse Event Death Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT

    MDR report key: 15094504 · Received July 25, 2022

    Report

    Report Number
    2210968-2022-05848
    Event Type
    Death
    Date Received
    July 25, 2022
    Date of Event
    October 25, 2021
    Report Date
    August 18, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 ¿G/M. 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. RELATED EVENTS CAPTURED VIA 2210968-2022-05845, 2210968-2022-05846, 2210968-2022-05847. CITATION: LANCET 2021; 398: 1687¿99. HTTPS://DOI.ORG/10.1016/S0140-6736(21)01548-8.

    Description of Event or Problem · 0

    TITLE: REDUCING SURGICAL SITE INFECTIONS IN LOW-INCOME AND MIDDLE-INCOME COUNTRIES (FALCON): A PRAGMATIC, MULTICENTRE, STRATIFIED, RANDOMISED CONTROLLED TRIAL. THE PRIMARY OBJECTIVE OF THE TRIAL WAS TO ASSESS WHETHER 2% ALCOHOLIC CHLORHEXIDINE VERSUS 10% POVIDONE¿IODINE FOR SKIN PREPARATION, OR TRICLOSAN-COATED SUTURE VERSUS NON-COATED SUTURE FOR FASCIAL CLOSURE, REDUCED SSI UP TO AND AT 30 DAYS AFTER SURGERY FOR CLEAN-CONTAMINATED AND CONTAMINATED OR DIRTY ABDOMINAL WOUNDS (DETAILS OF DEFINITIONS IN THE APPENDIX PP 2¿4). THE SECONDARY OBJECTIVES REPORTED IN THIS PAPER WERE TO ASSESS THE EFFECT OF THE TRIAL INTERVENTIONS ON SSI AT DISCHARGE, REOPERATION FOR SSI, MORTALITY, UNPLANNED WOUND OPENING, LENGTH OF INDEX HOSPITAL ADMISSION, READMISSION, AND RETURN TO NORMAL ACTIVITIES, ALL WITHIN 30 DAYS OF SURGERY. THE OTHER SECONDARY OBJECTIVES (RESISTANCE OF ORGANISMS ISOLATED FROM WOUND SWABS TO PROPHYLACTIC ANTIBIOTICS ADMINISTERED AND HEALTH-CARE RESOURCE USAGE) WILL BE REPORTED IN SEPARATE, PRE-PLANNED ANALYSES. BETWEEN DEC 10, 2018, AND SEPT 7, 2020, 5788 PATIENTS (3091 IN CLEAN-CONTAMINATED STRATUM, 2697 IN CONTAMINATED OR DIRTY STRATUM) WERE RANDOMISED (1446 TO ALCOHOLIC CHLORHEXIDINE AND NON-COATED SUTURE, 1446 TO ALCOHOLIC CHLORHEXIDINE AND TRICLOSAN-COATED SUTURE, 1447 TO AQUEOUS POVIDONE¿IODINE AND NON-COATED SUTURE, AND 1449 TO AQUEOUS POVIDONE¿IODINE AND TRICLOSAN-COATED SUTURE). 14·0% (810/5788) OF PATIENTS WERE CHILDREN AND 66·9% (3873/5788) HAD EMERGENCY SURGERY. THE INTERVENTIONAL ARM FOR CLOSURE OF THE FASCIAL SHEATH OF THE ABDOMINAL WALL WAS THE USE OF TRICLOSAN-COATED SUTURES. POLYDIOXANONE TRICLOSAN COATED SUTURES (ETHICON PDS PLUS; RARITAN, NJ, USA) ARE COMMERCIALLY AVAILABLE AND WERE USED IN ADULTS. VICRYL TRICLOSAN COATED SUTURES (ETHICON VICRYL PLUS; RARITAN, NJ, USA) WERE ALLOWED FOR PAEDIATRIC PATIENTS, ACCORDING TO SURGEON PREFERENCE. REPORTED COMPLICATIONS INCLUDE OVERALL MORTALITY RATES WITHIN 30 DAYS OF SURGERY (N=158) CONSIDERED AS SERIOUS ADVERSE EVENTS; OVERALL SURGICAL SITE INFECTION (N=562) REQUIRING REOPERATION; UNKNOWN EVENT REQUIRING READMISSION WITHIN 30 DAYS OF SURGERY (N=81), UNPLANNED WOUND OPENING WITHIN 30 DAYS OF SURGERY (N=501). IN CONCLUSION, BOTH OVERALL AND PER STRATUM REPORTED SSI RATES WERE HIGH, CONFIRMING THAT SPECIFIC ASSESSMENT OF PATIENTS FOR SSIS WILL LEAD TO THEIR HIGHEST DETECTION.26 THIS FINDING HIGHLIGHTS THE QUALITY OF THE FALCON TRIAL PROCESSES, INCLUDING PROACTIVE TRAINING OF MASKED OUTCOME ASSESSORS AND HIGH COMPLETION OF FOLLOW-UP. THESE VERY HIGH SSI RATES REPRESENT A PREVENTABLE COMPLICATION THAT IS CAUSING UNNECESSARY SUFFERING AND BURDEN TO PATIENTS AND SYSTEMS. SMALL RANDOMISED TRIALS SHOULD NOW BE AVOIDED AND SHOULD BE REPLACED WITH LARGER TRIALS THAT CAN MORE ROBUSTLY IDENTIFY OR REFUTE PRAGMATIC SOLUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394248 PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R