BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 24691282 · Received March 25, 2026

    Report

    Report Number
    2210968-2026-03079
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    June 3, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. 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: INJURY. 2025 AUG;56(8):112511. HTTPS://DOI.ORG/10.1016/J.INJURY.2025.112511. EPUB 2025 JUN 3. PMID: 40483941.

    Description of Event or Problem · 0

    TITLE: INCREASED WOUND COMPLICATIONS IN GLABROUS SKIN WITH ABSORBABLE SUTURES FOLLOWING CARPAL TUNNEL AND TRIGGER FINGER RELEASE. THE AIM OF THIS STUDY IS TO INVESTIGATE WHETHER INCISIONS CLOSED WITH MONOCRYL SUTURES DISPLAYED HIGHER WOUND COMPLICATION RATES THAN NYLON SUTURES FOLLOWING CARPAL TUNNEL AND TRIGGER FINGER RELEASE SURGERY. BETWEEN JUNE 2023 TO JUNE 2024, A TOTAL OF 155 CARPAL TUNNEL OR TRIGGER FINGER RELEASE IN 138 PATIENTS. INCISIONS WERE CLOSED USING EITHER 4¿0 POLIGLECAPRONE 25 (MONOCRYL) OR 4¿0 NYLON (ETHILON). REPORTED COMPLICATIONS ARE MONOCRYL GROUP N=8; DEHISCENCE TREATMENT: WOUND CARE N=3; INFECTION REQUIRING ANTIBIOTICS N=1; INFECTION REQUIRING I&D N=1; STITCH PROTRUSION TREATMENT: NOT MENTIONED. NYLON GROUP N=2; DEHISCENCE TREATMENT: WOUND CARE N=2; INFECTION REQUIRING ANTIBIOTICS N=1; STITCH PROTRUSION TREATMENT: NOT MENTIONED N=3; OTHER (UNSPECIFIED COMPLICATIONS) TREATMENT: NOT MENTIONED. IN CONCLUSION, VARIOUS FACTORS, INCLUDING INFLAMMATORY ARTHRITIS, JUNIOR RESIDENT INVOLVEMENT, AND THE TYPE OF SURGERY, WERE IDENTIFIED AS INDEPENDENT PREDICTORS OF WOUND COMPLICATIONS. DESPITE THE CONVENIENCE AND REDUCED POSTOPERATIVE FOLLOW-UP ASSOCIATED WITH ABSORBABLE SUTURES, THEIR HIGHER COMPLICATION RATES CALL FOR CAREFUL CONSIDERATION IN SUTURE SELECTION FOR GLABROUS SKIN CLOSURES. FURTHER RESEARCH AND STANDARDIZED GUIDELINES ARE NECESSARY TO OPTIMIZE SUTURE CHOICE, ENHANCE PATIENT OUTCOMES, AND REDUCE HEALTHCARE COSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748060 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention