BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19006392 · Received March 29, 2024

    Report

    Report Number
    2210968-2024-03674
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    July 10, 2021
    Report Date
    March 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. CITATION: (B)(6).

    Description of Event or Problem · 0

    TITLE: COMPARISON OF HANDMADE ENDOLOOP VERSUS POLYMERIC ENDOCLIP FOR STUMP CLOSURE IN LAPAROSCOPIC APPENDECTOMY THIS STUDY AIMED TO ESTABLISH WHETHER THE HANDMADE ENDOLOOP OR POLYMERIC ENDOCLIP METHOD WAS MORE EFFECTIVE FOR STUMP CLOSURE IN LAPAROSCOPIC APPENDECTOMY. BETWEEN (B)(6) 2017 AND (B)(6) 2019, 76 PATIENTS WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 45 MALES AND 41 FEMALES. FOR STUMP CLOSURE, THE POLYMERIC ENDOCLIP METHOD WAS USED IN 37 PATIENTS (MEAN AGE: 33 YEARS, RANGE: 18-74) AND THE HANDMADE ENDOLOOP METHOD IN 39 PATIENTS (MEAN AGE: 27 YEARS, RANGE: 18-65). FOR THE HANDMADE ENDOLOOP, A 2/0 VICRYL (ETHICON) SUTURE WAS USED. ALL PATIENTS WERE PREOPERATIVELY ADMINISTERED 1 G OF I.V. CEFAZOLIN FOR PROPHYLAXIS. IN ALL OPERATIONS, THE MESOAPPENDIX WAS DISSECTED USING A COMPETITOR LIGASURE (MANUFACTURER: COVIDIEN). REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N=3). IN CONCLUSION, WE CONCLUDE THAT BOTH STUMP CLOSURE METHODS ARE SAFE, AND THE MORE EASILY ACCESSIBLE HANDMADE ENDOLOOP METHOD CAN BE PERFORMED RELIABLY IN ALL HOSPITALS, INCLUDING SECONDARY HEALTHCARE FACILITIES SUCH AS SMALL HOSPITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388831 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention