BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19149818 · Received April 20, 2024

    Report

    Report Number
    2210968-2024-04634
    Event Type
    Injury
    Date Received
    April 20, 2024
    Date of Event
    July 4, 2022
    Report Date
    April 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1111/ANS.17923.

    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. ADDITIONAL INFORMATION: NOTE: RELATED EVENTS REPORTED VIA 2210968-2024-05008.

    Description of Event or Problem · 0

    TITLE: LOOP AND DRAIN TECHNIQUE FOR PREVENTION OF SURGICAL SITE INFECTION IN UPPER GASTROINTESTINAL SURGERY. THE AIM OF THIS STUDY IS TO COMPARE THE EFFECTIVENESS OF THE ¿LOOP AND DRAIN TECHNIQUE (LDT)¿, A COMBINATION METHOD UTILIZING A CONTINUOUS SUBCUTANEOUS VESSEL LOOP AND SUBCUTICULAR SUTURE FOR SURGICAL WOUND CLOSURE IN PATIENTS UNDERGOING UPPER GASTROINTESTINAL SURGERY. A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT AN UPPER GASTROINTESTINAL PROCEDURE WAS CONDUCTED BETWEEN 2017 AND 2019. A TOTAL OF 200 ADULT PATIENT IN WHICH 77 PATIENTS IN THE LDT GROUP, AND 123 PATIENTS INCLUDED IN THE CONTROL GROUP ARE INCLUDED IN THIS STUDY. DURING THE PROCEDURE, IN LDT GROUP, IT WAS PERFORMED IN A STANDARD FASHION AT THE END OF EACH OPERATION. THE DEEP FASCIA WAS CLOSED WITH PDS, 1¿2 VESSEL LOOPS WERE INSERTED IN THE SUPERFICIAL FASCIAL LAYER AND THE SKIN CLOSED USING A SUBCUTICULAR MONOCRYL SUTURE. REPORTED COMPLICATION: SURGICAL SITE INFECTION (N-?). CONCLUSION: THE ABSOLUTE REDUCTION IN THE OVERALL SSI RATES OF 14% MIRRORS THE EFFECTIVENESS OF OUR LDT TECHNIQUE AND CONFIRMS ITS ABILITY TO PREVENT SSIS. PROSPECTIVE FUTURE STUDIES MAY INCLUDE AN ANALYSIS WHICH INCLUDES INTRAOPERATIVE FACTORS AND COMPARING THE LDT TO THE NEGATIVE PRESSURE WOUND THERAPY TO PREVENT POST-OPERATIVE WOUND INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111100 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention