BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 19237788 · Received May 3, 2024

    Report

    Report Number
    2210968-2024-05087
    Event Type
    Injury
    Date Received
    May 3, 2024
    Report Date
    May 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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: 2210968-2024-05088, 2210968-2024-05089. CITATION: IRISH JOURNAL OF MEDICAL SCIENCE (1971 -) (2022) 191 (SUPPL 6):S187-S237 VOL.:(0123456789) 1 3 HTTPS://DOI.ORG/10.1007/S11845-022-03228-Y.

    Description of Event or Problem · 0

    TITLE: WOUND IRRIGATION IN THE PREVENTION OF SURGICAL SITE INFECTION IN ELECTIVE COLORECTAL SURGERY THE AIM OF THIS STUDY IS TO INVESTIGATE THE INCIDENCE OF SSI WITHIN 30 DAYS OF ELECTIVE COLORECTAL SURGERY IN PATIENTS WHO UNDERWENT WOUND IRRIGATION WITH PULSE LAVAGE VS STANDARD CLOSURE. A RETROSPECTIVE STUDY WAS CONDUCTED AT A UNIVERSITY HOSPITAL OVER A TWO-YEAR PERIOD BETWEEN (B)(6) 2020 AND (B)(6) 2021. ALL PATIENTS WHO UNDERWENT ELECTIVE COLORECTAL SURGERY WERE INCLUDED. STANDARD CLOSURE WAS DEFINED AS PDS AND CLIPS TO THE SKIN. THE INTERVENTION GROUP UNDERWENT PULSE LAVAGE USING AND CLOSURE WITH PDS AND 2-0 VICRYL AND 4-0 MONOCRYL. 76 PATIENTS UNDERWENT PULSE-LAVAGE WHILE 146 UNDERWENT STANDARD CLOSURE. SURGICAL SITE INFECTION (N-39) THESE DATA DEMONSTRATED A REDUCTION IN THE INCIDENCE OF SSI IN PATIENTS WHO UNDERWENT PULSE-LAVAGE. ALTHOUGH IT DID NOT REACH STATISTICAL SIGNIFICANCE, IT WARRANTS FURTHER INVESTIGATION IN THE SETTING OF COLORECTAL SURGERY. OBSERVED INFECTION RATES WERE IN KEEPING WITH THE LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493301 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other