BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL PDS PLUS UNKNOWN

    MDR report key: 21796253 · Received April 8, 2025

    Report

    Report Number
    2210968-2025-03686
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    April 30, 2024
    Report Date
    April 8, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: CUREUS. 2024 APR 30;16(4): E59339. HTTPS://DOI.ORG/10.7759/CUREUS.59339. PMID: 38689675; PMCID: PMC11060616.

    Description of Event or Problem · 0

    TITLE: SINGLE-CENTER EXPERIENCES: A COMPARISON OF INTRACORPOREAL AND EXTRACORPOREAL ANASTOMOSIS OUTCOMES IN RIGHT HEMICOLECTOMY. THIS SINGLE-CENTER RETROSPECTIVE COHORT STUDY COMPARED THE RETURN OF BOWEL FUNCTION AND OTHER ASSOCIATED EARLY PATIENT OUTCOMES AND MORBIDITY RATES AFTER AN INTRACORPOREALLY (ICA) OR EXTRACORPOREALLY (ECA) IN LAPAROSCOPIC RIGHT HEMICOLECTOMY (LRH). NINETY PARTICIPANTS WITH THE ANASTOMOTIC TYPE EVENLY DISTRIBUTED; 45 IN ICA (MALE=25, FEMALE=20) AND 45 IN ECA (MALE=28, FEMALE=17), WHO UNDERWENT LAPAROSCOPIC RIGHT HEMICOLECTOMY (LRH) USING 3-0 PDS STRATAFIX (ETH) FROM JANUARY 2021 TO SEPTEMBER 2023. REPORTED COMPLICATIONS ARE 3-0 PDS CROTCH STITCH (ETH) 3-0 PDS STRATAFIX (ETH) PARALYTIC ILEUS (N=20) TREATMENT NOT REPORTED. ANASTOMOTIC LEAK (N=2) TREATMENT NOT REPORTED. SURGICAL SITE INFECTION (N=10) TREATMENT NOT REPORTED. WOUND DEHISCENCE (N=5) TREATMENT NOT REPORTED. INCISIONAL HERNIA (N=1) TREATMENT NOT REPORTED. LOWER GASTROINTESTINAL BLEED (N=6) TREATMENT NOT REPORTED. INTESTINAL OBSTRUCTION (N=4) TREATMENT NOT REPORTED. IN CONCLUSION, THIS SINGLE-CENTER EXPERIENCE SHOWED THAT ICA IS ASSOCIATED WITH A QUICKER RETURN TO NORMAL BOWEL FUNCTION AND LOW MORBIDITY OUTCOMES. ICA PARTICIPANTS WERE POSITIVELY ASSOCIATED WITH CLINICALLY RELEVANT AND HEALTH ECONOMICS OUTCOMES OF SHORTER HOSPITAL STAYS WITHOUT SIGNIFICANTLY ADDING TO THE PROCEDURE'S DURATION TIMES OR COMPROMISING PRINCIPLES OF ONCOLOGICAL RESECTION YIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490743 STRATAFIX SPIRAL PDS PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other