BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 22155080 · Received June 5, 2025

    Report

    Report Number
    2210968-2025-06397
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    April 8, 2024
    Report Date
    June 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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: J. CLIN. MED. 2024, 13, 2142. HTTPS://DOI.ORG/10.3390/JCM13072142.

    Description of Event or Problem · 0

    TITLE: EYELID SKIN GRAFTING IN YOUNG PATIENTS WITH FACIAL NERVE PALSY. THIS SINGLE-CENTER, RETROSPECTIVE, OBSERVATIONAL, CONSECUTIVE CASE SERIES STUDY AIMS TO REPORT THE FUNCTIONAL AND COSMETIC OUTCOMES OF EYELID FULL-THICKNESS SKIN GRAFTS IN THE SURGICAL REHABILITATION OF ADULTS UNDER THE AGE OF 50 YEARS WITH FACIAL NERVE PALSY (FNP). BETWEEN FEBRUARY 2013 AND MAY 2019, A TOTAL OF 8 PATIENTS (MALE=3, FEMALE=5) UNDERWENT PERIOCULAR SKIN GRAFTING FOR FACIAL NERVE PALSY. THE FULL-THICKNESS SKIN GRAFT WAS DEFATTED, PLACED INTO THE DESIRED AREA, AND SUTURED USING QUILTING AND CONTINUOUS 6.0 MONOCRYL (ETHICON, RARITAN, NJ, USA) SUTURES. THE HARVEST SITE WAS CLOSED USING A 5¿0 MONOCRYL (ETHICON) CONTINUOUS INTERLOCKING SUTURE WITH OR WITHOUT DEEP INTERRUPTED SUTURES, AS NEEDED. REPORTED COMPLICATIONS ARE 5¿0 MONOCRYL (ETHICON), 6.0 MONOCRYL (ETHICON, RARITAN, NJ, USA), CASE 1 (N=1, AGE=43), PERSISTENT LAGOPHTHALMOS AND CORNEAL EPITHELIOPATHY, TREATMENT: MEDIAL TARSORRHAPHY. IN CONCLUSION, TO THE BEST OF OUR KNOWLEDGE, THIS EXPERIENCE OF EYELID SKIN GRAFTING WITHIN A YOUNG PATIENT POPULATION WITH FACIAL NERVE PALSY IS THE FIRST TO BE REPORTED TO DATE. THUS, WITHIN THE LIMITATION OF A SMALL SAMPLE SIZE, THIS AUDIT DETERMINED WHETHER SKIN GRAFTING COULD BE RECOMMENDED TO YOUNGER PEOPLE AND IS USEFUL TO CONSIDER IN THEIR CONSENTING. TAKEN TOGETHER, THIS MAY BE CONSIDERED A PILOT STUDY YIELDING RESULTS THAT PROVIDE PRELIMINARY EVIDENCE OF THE FEASIBILITY OF THIS APPROACH IN YOUNGER FNP PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493266 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Required Intervention