BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24314157 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01507
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    July 31, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. 2025 JUL 31;14(15):5397. HTTPS://DOI.ORG/10.3390/JCM14155397. PMID: 40807017; PMCID: PMC12347116.

    Description of Event or Problem · 0

    TITLE: DOPPLER-GUIDED HAEMORRHOIDAL ARTERY LIGATION AND RECTOANAL REPAIR (HAL-RAR): AN INSTITUTIONAL EXPERIENCE. THE AIM OF THIS STUDY IS TO EVALUATE THE SAFETY, SHORT-TERM EFFICACY, AND RECURRENCE RATES ASSOCIATED WITH HAL-RAR (HAEMORRHOIDAL ARTERY LIGATION WITH RECTOANAL REPAIR) AS A TREATMENT OPTION FOR HAEMORRHOIDS. SECONDARY OUTCOMES INCLUDE LENGTH OF STAY AND PERIOPERATIVE COMPLICATION RATES. BETWEEN 2 FEBRUARY 2022 AND 2 DECEMBER 2024, A TOTAL OF 128 PATIENTS WHO UNDERWENT ELECTIVE DOPPLER-GUIDED HAL-RAR USING 2/0 ABSORBABLE SUTURES (VICRYL). REPORTED COMPLICATIONS ARE: N=5; POSTOPERATIVE URINARY RETENTION, TREATMENT: INSERTION OF AN INDWELLING CATHETER (IDC) AND A TRIAL OF VOID (TOV), N=1; PERSISTENT POSTOPERATIVE BLEEDING, TREATMENT: SUTURE HAEMOSTASIS, N=4; PER-RECTAL BLEEDING, TREATMENT: NOT MENTIONED, N=3; CONSTIPATION, TREATMENT: NOT MENTIONED, N=2; PAIN, TREATMENT NOT MENTIONED, N=22; SYMPTOMATIC RECURRENCE, BLEEDING ONLY- 9, PROLAPSE ONLY- 11, BOTH- 2, RE-INTERVENTION (12 PATIENTS), REDO HALRAR- 58.3%, PHENOL INJECTION- 16.7%, EXCISIONAL HAEMORRHOIDECTOMY- 25%. IN CONCLUSION, HAL-RAR IS A SAFE, EFFECTIVE, AND LOW-MORBIDITY OPTION FOR THE MANAGEMENT OF GRADE II AND III HAEMORRHOIDS, SUITABLE FOR DAY-CASE SURGERY. IN SELECTED GRADE IV CASES, IT MAY OFFER BENEFIT, ALTHOUGH WITH HIGHER RECURRENCE AND CONVERSION RISK. CAREFUL PATIENT SELECTION IS ESSENTIAL, AND LONGER-TERM PROSPECTIVE STUDIES ARE NEEDED TO ASSESS DURABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379416 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention