BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22173030 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06543
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    January 14, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INTERNATIONAL JOURNAL OF GASTROINTESTINAL INTERVENTION 13.1 PP.11-15 (2024): 11. HTTPS://DOI.ORG/10.18528/IJGII240002.

    Description of Event or Problem · 0

    USE OF CRYOPRESERVED, ULTRA-THICK AMNIOTIC MEMBRANE ALLOGRAFT FOR COLORECTAL AND INTESTINAL ANASTOMOSES. THIS STUDY AIMS TO ASSESS THE SAFETY AND EFFECTIVENESS OF ULTRA-THICK AMNIOTIC MEMBRANE (AM) GRAFT IN PREVENTING AL IN PATIENTS UNDERGOING INTESTINAL SURGERY. BETWEEN JANUARY 2016 AND JANUARY 2023, A TOTAL OF 11 PATIENTS (MALE=7, FEMALE=4) UNDERWENT COLORECTAL AND INTESTINAL SURGERY WITH ADJUNCTIVE CRYOPRESERVED, ULTRA-THICK AM WHILE USING 2-0 AND 3-0 VICRYL SUTURES. REPORTED COMPLICATIONS ARE 2-0 AND 3-0 VICRYL SUTURES (ETH). ILEUS N=1 TREATMENT: NOT REPORTED. POST-SURGICAL PAIN N=9. TREATMENT: NARCOTICS (HYDROCODONE/ACETAMINOPHEN). IN CONCLUSION, THESE PRELIMINARY FINDINGS SUGGEST CRYOPRESERVED, ULTRA-THICK AM IS SAFE AND MAY HELP PREVENT AL AND POST-OPERATIVE COMPLICATIONS FOLLOWING COLORECTAL AND INTESTINAL SURGERY. LARGER PROSPECTIVE, RANDOMIZED, CONTROLLED TRIALS ARE WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401386 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention