BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23014737 · Received September 10, 2025

    Report

    Report Number
    2210968-2025-10279
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    January 9, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: ACTA NEUROCHIR (WIEN). 2025 JAN 9;167(1):7. HTTPS://DOI.ORG/10.1007/S00701-024-06391-6 PMID: 39786449; PMCID: PMC11717893.

    Description of Event or Problem · 0

    TITLE: INTRA-INDIVIDUAL COMPARISON OF LONG-TERM OUTCOMES BETWEEN COMBINED AND INDIRECT BYPASS SURGERY IN ADULT MOYAMOYA DISEASE. THE AIM OF THIS STUDY IS TO PRESENT THE 896 PATIENTS WHO UNDERWENT 1084 BYPASS SURGERIES BETWEEN 2007 AND 2021, 24 PATIENTS WITH MMD WHO UNDERWENT COMBINED BYPASS ON ONE SIDE AND INDIRECT BYPASS ON THE OTHER SIDE WERE ULTIMATELY ENROLLED IN THIS STUDY. PROLENE SUTURE (ETH) WAS USED TO ANASTOMOSED IN AN END-TO-SIDE FASHION OF THE STA AND DISTAL MCA. REPORTED COMPLICATIONS: PROLENE SUTURE (ETH). COMBINED BYPASS (N=24). CEREBRAL HYPERPERFUSION SYNDROME (N=7). TREATMENT: NOT REPORTED. CEREBRAL INFARCTION (N=3). TREATMENT: NOT REPORTED. IN CONCLUSION, COMBINED BYPASS MAY BE A MORE EFFECTIVE TREATMENT OPTION FOR MMD BASED ON ITS HIGHER REVASCULARIZATION AREA AND FAVORABLE HEMODYNAMIC RESULTS COMPARED TO INDIRECT BYPASS IN THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952612 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other