BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 24264875 · Received February 4, 2026

    Report

    Report Number
    2210968-2026-01318
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 4, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: CUREUS. 2026 JAN 7;18(1): E100974. HTTPS://DOI.ORG/10.7759/CUREUS.100974. PMID: 41509574; PMCID: PMC12775883.

    Description of Event or Problem · 0

    TITLE: SUBCUTANEOUS EMPHYSEMA FOLLOWING TRACHEOCUTANEOUS FISTULA CLOSURE IN A PEDIATRIC PATIENT: A CASE REPORT. THIS IS A CASE STUDY OF A 4-YEAR-OLD BOY PRESENTED TO OUR CLINIC WITH A PERSISTENT TRACHEOCUTANEOUS FISTULA UNDERWENT PRIMARY SURGICAL REPAIR UNDER GENERAL ANESTHESIA. THE TRACHEAL OPENING AND OVERLYING MUSCLE WERE CLOSED WITH VICRYL SUTURES, AND THE SKIN WAS CLOSED USING MONOCRYL SUTURES. REPORTED COMPLICATIONS ARE: N=1; 4-YEAR-OLD MALE, DEVELOPED GENERALIZED BODY, NECK, AND FACIAL SWELLING, ACCOMPANIED BY DIFFICULTY BREATHING, DIFFUSE SUBCUTANEOUS CREPITUS WAS NOTED, SURGICAL EMPHYSEMA, TREATMENT: EMERGENCY TRACHEOSTOMY. IN CONCLUSION, TCF CLOSURE IS GENERALLY A SAFE AND EFFECTIVE PROCEDURE, BUT COMPLICATIONS SUCH AS SUBCUTANEOUS EMPHYSEMA CAN OCCUR, ESPECIALLY IN PEDIATRIC PATIENTS WITH COMPLEX MEDICAL HISTORIES. THIS CASE HIGHLIGHTS THE IMPORTANCE OF EARLY RECOGNITION AND PROMPT MANAGEMENT OF SUBCUTANEOUS EMPHYSEMA TO PREVENT AIRWAY COMPROMISE AND FURTHER COMPLICATIONS. WHILE PRIMARY CLOSURE REMAINS THE MOST COMMON METHOD, CAREFUL PATIENT SELECTION AND CLOSE POSTOPERATIVE MONITORING ARE CRUCIAL FOR SUCCESSFUL OUTCOMES. FUTURE STUDIES ARE NEEDED TO EVALUATE LONG-TERM OUTCOMES AND TO COMPARE THE EFFICACY OF DIFFERENT SURGICAL TECHNIQUES IN REDUCING THE RATE OF COMPLICATIONS LIKE SUBCUTANEOUS EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316813 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention