BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22233668 · Received June 17, 2025

    Report

    Report Number
    2210968-2025-06961
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    March 3, 2025
    Report Date
    June 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: J CLIN GASTROENTEROL. 2025 MAR 1;59(3):269-275. DOI: 10.1097/MCG.0000000000002009. PMID: 38648497; PMCID: PMC11809737. HTTPS://DOI.ORG/10.1097/MCG.0000000000002009.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    COMPARISON OF 1-STAGE AND 2-STAGE MANAGEMENTS FOR COMMON BILE DUCT STONES AND GALLSTONES (CBDS): A RETROSPECTIVE STUDY. THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY, SAFETY, AND SURGICAL OUTCOMES OF 2-STAGE MANAGEMENT, NAMELY PREOPERATIVE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) + LAPAROSCOPIC CHOLECYSTECTOMY (ERCP+LC) OR LC + POSTOPERATIVE ERCP (LC+ERCP), AS WELL AS 1-STAGE MANAGEMENT, LC + LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) FOR TREATING PATIENTS WITH GALLSTONES AND COMMON BILE DUCT STONES (CBDS). BETWEEN JANUARY 2019 AND JUNE 2021, A TOTAL OF 180 PATIENTS WITH GALLSTONES AND CBDS ADMITTED TO THE DEPARTMENT OF GENERAL SURGERY OF TONGJI HOSPITAL. SEX (M/F) GROUP 1 (30/30); GROUP 2 (31/29); GROUP 3 (32/28). AGE (Y) GROUP 1 (61.03 ± 11.89); GROUP 2 (61.63 ± 12.44); GROUP 3 (61.72 ± 14.06) THE STUDY INCLUDED 3 GROUPS: ERCP+LC (GROUP 1), LC +ERCP (GROUP 2), AND LC+LCBDE (GROUP 3), EACH CONSISTING OF 60 PATIENTS. VICRYL SUTURE (3-0 ABSORBABLE; ETHICON) WAS USED TO CLOSED THE COMMON BILE DUCT. REPORTED COMPLICATIONS ARE : VICRYL SUTURE (3-0 ABSORBABLE; ETHICON) BILE LEAK: 1MONTH (N=3). TREATMENT : THEY WERE TREATED CONSERVATIVELY BLEEDING : 1 MONTH (N=3). TREATMENT : PATIENTS WITH BLEEDING AND PANCREATITIS WERE TREATED CONSERVATIVELY PANCREATITIS : 1 MONTH [GROUP 1 (N=2); GROUP 2 (N=). TREATMENT : GROUP 1 : PATIENTS WITH BLEEDING AND PANCREATITIS WERE TREATED CONSERVATIVELY; GROUP 2 : ONE PATIENT, WHO HAD PANCREATITIS DUE TO A RETAINED STONE IN THE CBD, UNDERWENT A SECOND ERCP TO SUCCESSFULLY REMOVE THE STONE. WOUND INFECTION : 1 MONTH (N=2). TREATMENT : THEY WERE TREATED CONSERVATIVELY -DUODENAL PERFORATION : 1 MONTH (N=1). TREATMENT : THE PATIENT WITH DUODENAL PERFORATION REQUIRED SURGERY FOR ASSISTANCE -BILIARY STRICTURE : 4 TO 5 YEARS AFTER TREATMENT (N=2). VICRYL SUTURE (3-0 ABSORBABLE; ETHICON) 81 YEARS OLD. -DIED OF MULTIPLE ORGAN DYSFUNCTION SYNDROME AFTER ERCP IN GROUP 1 (N=1) TREATMENT : NOT REPORTED. IN CONCLUSION, BOTH 1-STAGE MANAGEMENT AND 2-STAGE MANAGEMENT ARE EFFECTIVE TREATMENTS FOR CBDS. THE LC+LCBDE MANAGEMENT IS A SAFE TREATMENT OPTION, OFFERING SHORTER HOSPITAL STAYS AND OPERATION DURATION, LOWER COSTS, AND FEWER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448542 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention