BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22474255 · Received July 10, 2025

    Report

    Report Number
    2210968-2025-08045
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    September 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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: DIS COLON RECTUM. 2024 DEC 1;67(12):1564-1575. HTTPS://DOI.ORG/10.1097/DCR.0000000000003502. EPUB 2024 SEP 6. PMID: 39250316.

    Description of Event or Problem · 0

    TITLE: LOCALIZED ADMINISTRATION OF MESENCHYMAL STEM CELL-DERIVED EXOSOMES FOR THE TREATMENT OF REFRACTORY PERIANAL FISTULA IN PATIENTS WITH CROHN'S DISEASE: A PHASE II CLINICAL TRIAL. THE AIM OF THIS NONRANDOMIZED, NONBLINDED SINGLE-CENTER PHASE II CLINICAL TRIAL. WAS TO EVALUATE THE EFFICACY OF MESENCHYMAL STEM CELL¿DERIVED EXOSOMES FOR THE TREATMENT OF REFRACTORY PERIANAL FISTULAS. BETWEEN JANUARY 2022 AND FEBRUARY 2024, A TOTAL OF 23 PATIENTS (12 MALE AND 11 FEMALE; MEAN AGE WAS 34.52 PLUS OR MINUS 11.02 YEARS) WERE ENROLLED AND ONLY 20 PATIENTS WHO COMPLETED THE FOLLOW-UP WERE ANALYSED. ALL PATIENTS UNDERWENT SETON PLACEMENT UNLESS CONTRAINDICATED (ETHIBOND EXCEL POLYESTER SUTURE, JOHNSON & JOHNSON). THE SETONS WERE REMOVED IF A CLINICAL RESPONSE WAS OBSERVED AND IF THE PATIENT HAD LOWER PUS DISCHARGE. REPORTED COMPLICATIONS INCLUDE: ETHIBOND EXCEL POLYESTER SUTURE (ETHICON): PATIENT NO. 14: 33-YEAR-OLD MALE (N=1) - PERSISTENT FISTULA TRACTS (NO FISTULA TRACTS HEALED; RESULT WAS UNRESPONSIVE) TREATMENT: NOT REPORTED. IN CONCLUSION, THIS STUDY DEMONSTRATED THAT UMBILICAL CORD MSC-DERIVED EXOSOMES ARE SAFE FOR THE TREATMENT OF PERIANAL FISTULAS IN PATIENTS WITH CROHN¿S DISEASE, PARTICULARLY THOSE WITH REFRACTORY TRACTS. FUTURE STUDIES WITH LARGER SAMPLE SIZES AND A CONTROL GROUP ARE NEEDED TO ESTABLISH THE DEFINITIVE EFFICACY RATE OF THIS TREATMENT MODALITY IN PATIENTS, PARTICULARLY THOSE WITH MULTIPLE TRACTS OR LARGER AND MORE COMPLEX ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678425 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Other