BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT

    MDR report key: 19239044 · Received May 3, 2024

    Report

    Report Number
    2210968-2024-05103
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    May 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 ¿ = 2360 ¿G/M. 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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-05102. CITATIONS : ANN GASTROENTEROL SURG.8:332¿341. HTTPS://DOI.ORG/10.1002/AGS3.12739.

    Description of Event or Problem · 0

    TITLE :RANDOMIZED CONTROLLED TRIAL OF OLANEXIDINE GLUCONATE AND POVIDONE IODINE FOR SURGICAL SITE INFECTION AFTER GASTROINTESTINAL SURGERY. THE AIM OF THE STUDY WAS TO DETERMINE WHETHER THE NOVEL ANTISEPTIC OLANEDINE ANTISEPTIC SOLUTION 1.5%® IS MORE EFFECTIVE THAN THE CONVENTIONAL ANTISEPTIC PI SOLUTION 10% MEIJI® AGAINST SSI THROUGH A COMPARATIVE INVESTIGATION AT THE CLINICAL SITES OF GASTROINTESTINAL SURGERY. BETWEEN AUGUST 2018 AND FEBRUARY,2021, 263 AND 262 PATIENTS WERE ASSIGNED TO THE OG AND PI GROUPS, RESPECTIVELY. FASCIA CLOSURE WAS PERFORMED VIA THE INTERRUPTED SUTURE TECHNIQUE USING ABSORBABLE BRAIDED YARN ( VICRYL PLUS®; ETHICON, INC.).SKIN CLOSURE WAS ALSO PERFORMED VIA THE INTERRUPTED SUTURE TECHNIQUE IN EVERY PATIENT USING ABSORBABLE MONOFILAMENT YARN (PDS PLUS®; ETHICON, INC.). THE REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION : SUPERFICIAL INCISIONAL (N=10),DEEP INCISIONAL (N=12),ORGAN/SPACE (N=52) AND SUPERFICIAL¿+¿DEEP INCISIONAL (N=22), LEAKAGE OF GASTROINTESTINAL ANASTOMOSIS (N=16), PANCREATIC FISTULA (N=27), POSTOPERATIVE HEMORRHAGE (N=9), AND ADVERSE SKIN REACTION : ERYTHEMA (N=4), PRURITUS (N=2). IN CONCLUSION, OG, AS A PREOPERATIVE SKIN ANTISEPTIC, DID NOT REDUCE THE OCCURRENCE RATE OF TOTAL SSI. HOWEVER, DEEP INCISIONAL SSI MAY BE REDUCED USING OG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030291 PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other