BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22335332 · Received June 26, 2025

    Report

    Report Number
    2210968-2025-07458
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    January 1, 2024
    Report Date
    June 26, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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: EUR REV MED PHARMACOL SCI. 2024 MAY;28(10):3642-3649. HTTPS://DOI.ORG/10.26355/EURREV_202405_36301 PMID: 38856140.

    Description of Event or Problem · 0

    TITLE: ANASTOMOTIC LEAKAGE FOLLOWING RECTAL CANCER LAPAROSCOPIC SURGERY: CAN A TRANSANAL DRAINAGE TUBE BE AN ALTERNATIVE TO DIVERTING STOMA? THE AIM OF THIS STUDY IS TO EVALUATE THE ROLE OF A TRANSANAL DRAINAGE TUBE COMPARED WITH A DIVERTING STOMA IN REDUCING THE RATE OF ANASTOMOSIS LEAKAGE AND LIMITING SURGICAL COMPLICATIONS. BETWEEN JULY 2018 TO OCTOBER 2022, A TOTAL OF 196 PATIENTS WITH RECTAL CANCER (CLINICAL STAGE I-III) UNDERWENT LAPAROSCOPIC LOW ANTERIOR RESECTION USING VICRYL 3.0 (VICRYL ETHICON). REPORTED COMPLICATIONS ARE N=?; ANASTOMOTIC LEAKAGE. TREATMENT: CONSERVATIVE AND REOPERATION N=?; BOWEL OBSTRUCTION. TREATMENT: NOT MENTIONED N=?; WOUND INFECTION. TREATMENT: NOT MENTIONED N=?; ANASTOMOTIC BLEEDING. TREATMENT: NOT MENTIONED N=?; URINARY RETENTION. TREATMENT: NOT MENTIONED N=?; BLADDER PARALYSIS. TREATMENT: NOT MENTIONED N=?; ABSCESS IN ABDOMEN. TREATMENT: NOT MENTIONED N=? DEEP VEIN THROMBOSIS. TREATMENT: NOT MENTIONED N=?; DERMATITIS. TREATMENT: NOT MENTIONED ILEAL PROLAPSE. TREATMENT: NOT MENTIONED ILEOSTOMY LEAKAGE. TREATMENT: NOT MENTIONED IN CONCLUSION, ANASTOMOSIS LEAKAGE IN SURGERY FOR RECTAL CANCER IS STILL CHALLENGING, AND THE CHOICE OF METHODS TO PROTECT THE ANASTOMOSIS IS STILL DEBATED. HOWEVER, THROUGH OUR STUDY, WE FOUND THAT THE TRANSANAL DRAINAGE TUBE IS A SIMPLE METHOD WITH EQUIVALENT VALUE TO DIVERTING STOMA FOR REDUCING AL AFTER LAPAROSCOPIC LAR FOR RECTAL CANCER, AVOIDING COMPLICATIONS RELATED TO ILEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792875 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention