BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8143659 · Received December 7, 2018

    Report

    Report Number
    2210968-2018-77591
    Event Type
    Injury
    Date Received
    December 7, 2018
    Report Date
    November 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 01/24/2019. CORRECTED INFORMATION: IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE CASES OF COMPLICATIONS IN POST-OPERATIVE WOUND HEALING PROCESS DESCRIBED IN THE SCIENTIFIC THESIS WERE NOT REPORTED TO ETHICON, BECAUSE ACCORDING TO THE SURGEONS, SUTURE MATERIAL WAS NOT THE CAUSE OF SAID PROBLEMS. STITCHES ETHILON BLUE WERE USED IN A MEDICAL TEST AT RANDOM AS A MONOFILAMENT SUTURE, WHICH WAS AVAILABLE IN THE CLINIC AT THAT TIME. THE MEDICAL TEST WAS ENTIRELY OBJECTIVE. SURGEON STRONGLY DENIED THE ETHILON BLUE SUTURE MATERIAL TO BE THE CAUSE OF FURTHER COMPLICATIONS IN THE WOUND HEALING PROCESS. WHILE SUTURING THE WOUNDS, THE SURGEON DID NOT SPOT ANY DEFECTS OR EVIDENCE OF ETHILON BLUE SUTURE MATERIAL¿S MALFUNCTIONING.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: POLSKI PRZEGLAD CHIRURGICZNY; 2016, 88, 4, 180¿187 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EVALUATION OF THE SURGERY WOUND HEALING PROCESS USING SELF-ADAPTIVE SKIN SUTURE OR MECHANICAL STAPLER". AUTHORS: EWA SZTUCZKA, MAREK JACKOWSKI, WIOLETTA ZUKOWSKA. CITATION: POLSKI PRZEGLAD CHIRURGICZNY; 2016, 88, 4, 180¿187. THE AIM OF THE STUDY WAS TO COMPARE THE RESULTS OF THE EARLY PERIOD OF SURGICAL WOUND HEALING PROCESS WITH ACCESS VIA LAPAROTOMY USING TECHNIQUES, WHICH ARE SELF-ADAPTIVE SUTURES AND MECHANICAL STAPLERS USED FOR SKIN CLOSURE. FROM SEP2009 TO DEC2011, 120 PATIENTS (N=73 MALE AND N=47 FEMALE; MEAN AGE OF 60.7±12.6 YEARS) UNDERGOING ELECTIVE AND EMERGENCY SURGERIES WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO THREE GROUPS OF DIFFERENT CLEANLINESS LEVEL: CLEAN WOUND (N=40); CLEAN/INFECTED WOUND (N=40); AND INFECTED/CONTAMINATED WOUND (N=40). MOREOVER THESE WERE EQUALLY DIVIDED INTO SUBGROUPS WITH DIFFERENT SUTURE TYPE TO TREAT THE SKIN INCISION OF THE SURGICAL WOUND: STAPLER (N=20 EACH GROUP) AND 2/0 ETHILON BLUE (N=20 EACH GROUP). IN ALL PATIENTS, PERITONEAL AND FASCIAL LAYER WERE CLOSED USING 0 PDS II SUTURE. OUTCOMES ON THE SUTURE SUBGROUPS (ETHILON BLUE) INCLUDED SUBCUTANEOUS HEMATOMA (N=1) IN CLEAN WOUND GROUP; SUBCUTANEOUS HEMATOMA WHICH BECAME INFECTED DESPITE EVACUATION (N=3) IN CLEAN/INFECTED WOUND GROUP; AND SURGICAL SITE INFECTION WITH EVIDENCE OF SEROSANGUINOUS OR PURULENT INFECTION (N=11) IN INFECTED/CONTAMINATED WOUND GROUP. THE ETHILON BLUE MONOFILAMENT SUTURE, IN SPITE OF ITS EFFECTIVE HAEMOSTATIC ACTION, INCREASES THE RISK OF COMPLICATIONS DURING THE HEALING PROCESS OF INFECTED/CONTAMINATED WOUNDS DUE TO THE MUCH GREATER TIGHTNESS OF ITS APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980678 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention