BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 18284433 · Received December 7, 2023

    Report

    Report Number
    2210968-2023-09566
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    July 13, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 2210968-2023-09565 AND 2210968-2023-09567. CITATION: 2022 JOURNAL OF PHARMACY AND BIOALLIED SCIENCES L. HTTPS://DOI.ORG/10.4103/JPBS.JPBS_736_21.

    Description of Event or Problem · 0

    TITLE: EVALUATION OF THE EFFICACY OF ISO AMYL 2 CYANOACRYLATE GLUE IN CLOSURE OF EXTRAORAL SURGICAL WOUND WHEN COMPARED WITH OTHER NON ABSORBABLE SUTURE MATERIALS A PROSPECTIVE CLINICAL STUDY. THE AIM OF THIS STUDY IS TO ASSESS THE EFFICIENCY OF ISO AMYL 2 CYANOACRYLATE GLUE IN CLOSURE OF EXTRAORAL SURGICAL WOUND WHEN COMPARED WITH OTHER SUTURE MATERIALS LIKE POLYPROPYLENE (PROLENE), NYLON (ETHILON) AND SILK (MERSILK). THIS PROSPECTIVE CLINICAL OBSERVATIONAL STUDY INCLUDES 60 SUBJECTS WHO WERE DIVIDED INTO TWO EQUAL GROUPS: SUTURE GROUP (POLYPROPYLENE (PROLENE), NYLON (ETHILON) AND SILK (MERSILK)) AND THE CYANOACRYLATE GROUP. REPORTED COMPLICATION: ITCHING? NO. BURNING? NO. ERYTHEMA? NO. SWELLING? NO. DEHISCENCE? NO. DISCHARGE? NO. WOUND NECROSIS? NO. PAIN? NO. ITCHING? NO. STIFFNESS? (?) CONCLUSION: ISO AMYL 2 CYANOACRYLATE CAN BE USED SUCCESSFULLY IN THE SUTURE CLOSURE WITH EXCELLENT PATIENT SATISFACTION AND CAN BE CONSIDERED AS AN ALTERNATIVE TO THE ROUTINE SUTURE MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213006 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other