BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 23726743 · Received December 5, 2025

    Report

    Report Number
    2210968-2025-13633
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    August 18, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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: J PEDIATR SURG. 2025 AUG 18:162570. HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2025.162570. EPUB AHEAD OF PRINT. PMID: 40834915.

    Description of Event or Problem · 0

    TITLE: INTERNAL TRACTION AS AN EFFECTIVE BRIDGE TO SUCCESSFUL ANASTOMOSIS IN COMPLEX ESOPHAGEAL ATRESIA. THE AIM OF THIS STUDY IS TO BENEFIT FROM OVERALL PATIENT AND ESOPHAGEAL GROWTH AND THE DEVELOPMENT OF ESOPHAGEAL POUCH TISSUES, ESPECIALLY WITH BOLUS GASTRIC FEEDING AND ASSOCIATED REFLUX. TWENTY-THREE PATIENTS UNDERWENT INTERNAL TRACTION: 14 PRESENTED WITH A GASLESS ABDOMEN AND 9 WITH DISTAL FISTULA. ETHIBOND (ETH) WHICH WAS USED IN THE UPPER AND LOWER POUCHES IN GROUP A AND GROUP B, WHILE PROLENE (ETH) WAS USED IN GROUP B ONLY. REPORTED COMPLICATIONS: ETHIBOND (ETH). GROUP A (N=14). CONSERVATIVELY MANAGED ESOPHAGEAL LEAK (N=1). TREATMENT: NOT REPORTED. UPPER POUCH WITH LOSS OF TENSION (N=2). TREATMENT: REQUIRING RE-TENSIONING. PERSISTENT LONG GAP (N=1). TREATMENT: REQUIRING RE-TENSIONING. DISTAL FISTULA (N=1). TREATMENT: REQUIRED STRICTURE RESECTION FOR A RECALCITRANT STRICTURE FOLLOWING ESOPHAGEAL AUTO-ANASTOMOSIS. PERSISTING ESOPHAGEAL LEAK. TREATMENT: REQUIRED REDO ESOPHAGEAL ANASTOMOSIS. ESOPHAGEAL STRICTURE (N=8). TREATMENT: UNDERWENT A MEDIAN OF 7.5 DILATATIONS. RECURRENT TRACHEOESOPHAGEAL FISTULA (N=2). TREATMENT: NOT REPORTED. ETHIBOND (ETH). PROLENE (ETH). GROUP B(N=9). CONSERVATIVELY MANAGED ESOPHAGEAL LEAK (N=1). TREATMENT: NOT REPORTED. PERSISTENT AIR LEAK (N=1). TREATMENT: REQUIRED REOPERATION. ESOPHAGEAL STRICTURE (N=4). TREATMENT: UNDERWENT A MEDIAN OF 7.5 DILATATIONS. RECURRENT TRACHEOESOPHAGEAL FISTULA (N=2). TREATMENT: NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863231 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention