BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 17385588 · Received July 24, 2023

    Report

    Report Number
    2210968-2023-05345
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    October 27, 2022
    Report Date
    July 24, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 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. CITATION CITE: JOURNAL OF HOSPITAL INFECTION 131 ( 2023) 99-106 HTTPS://DOI.ORG/10.1016/J.JHIN.2022.10.005

    Description of Event or Problem · 0

    TITLE: COMPARING THE EFFICACY OF POVIDONE-IODINE AND NORMAL SALINE IN INCISIONAL WOUND IRRIGATION TO PREVENT SUPERFICIAL SURGICAL SITE INFECTION: A RANDOMIZED CLINICAL TRIAL IN GASTRIC SURGERY. THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACIES OF WOUND IRRIGATION WITH NORMAL SALINE (NS) AND POVIDONE IODINE (PVI) FOR THE PREVENTION OF SSI AFTER GASTRECTOMY AND TO IDENTIFY THE RISK FACTORS FOR SSI. THIS RANDOMIZED, SINGLE-CENTRE CLINICAL TRIAL WAS CONDUCTED AT A (B)(6) HOSPITAL, (B)(6) FROM MAY 2015 TO DECEMBER 2018 INCLUDED 340 PATIENTS WITH GASTRIC CANCER UNDERGOING GASTRECTOMY. SIZE 4-0 VICRYL PLUS INTRADERMIC SUTURES WERE USED IN ALL PATIENTS. REPORTED COMPLICATIONS: SURGICAL SITE INFECTION (N-10) INTRA-ABDOMINAL INFECTION (N- 5) INTRA-ABDOMINAL BLEEDING (N-1) CONCLUSION: NS AND PVI HAD SIMILAR EFFICACY AS PROPHYLACTIC WOUND IRRIGATION FOR THE PREVENTION OF SSI AFTER GASTRECTOMY. THE RISK OF SSI WAS HIGHER IN PATIENTS WITH HIGH BMI OR POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598461 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other