BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 18564416 · Received January 23, 2024

    Report

    Report Number
    2210968-2024-00602
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    May 12, 2022
    Report Date
    January 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 2360 ¿G/M. 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: THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2022. HTTPS://DOI.ORG/10.1007/S00464-022-09260-4. RELATED EVENTS CAPTURED VIA: 2210968-2024-00601, 2210968-2024-00602, 2210968-2024-00603.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: H6. HEALTH EFFECT - IMPACT CODE. RELATED EVENTS CAPTURED VIA: 2210968-2024-00601, 2210968-2024-00603, 2210968-2024-00812. 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. PRODUCT COMPLAINT # (B)(4). CORRECTED: D1. BRAND NAME, D2A. COMMON DEVICE NAME, D2B, G4. COMBINATION PRODUCT (NO) RELATED EVENTS CAPTURED VIA: 2210968-2024-00601, 2210968-2024-00603, 2210968-2024-00812. 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.

    Description of Event or Problem · 0

    TITLE: EFFECT OF STAPLED VERSUS LAYERED SKIN CLOSURE ON SURGICAL SITE OCCURRENCES AFTER ABDOMINAL WALL RECONSTRUCTION. THE AIM OF THIS STUDY IS TO COMPARE THE EFFECT OF SKIN CLOSURE TECHNIQUE ON SURGICAL SITE OCCURRENCES (SSO) AFTER OPEN ABDOMINAL WALL RECONSTRUCTION (AWR) WITH RETROMUSCULAR POLYPROPYLENE MESH PLACEMENT. BETWEEN JANUARY 1, 2013 AND FEBRUARY 1, 2020, A TOTAL OF 834 PATIENTS UNDERWENT OPEN AWR AND MET THE INCLUSION CRITERIA. THE GROUPS WERE DIVIDED INTO TWO. IN 263 OF THESE PATIENTS, STAPLES WERE USED FOR CLOSURE (CONTROL GROUP) WHILE IN THE REMAINING 571 PATIENTS, SUBCUTICULAR SUTURE AND CYANOACRYLATE SKIN ADHESIVE WITH OR WITHOUT POLYMER MESH TAPE WERE USED (STUDY GROUP). THE LAYERED CLOSURE WAS CHARACTERIZED BY CLOSING SCARPA¿S FASCIA AND THE DEEP DERMIS WITH INTERRUPTED SUTURE 2¿0 VICRYL AND THE SKIN WAS CLOSED WITH SUBCUTICULAR ABSORBABLE SUTURE 4¿0 MONOCRYL AND CYANOACRYLATE SKIN ADHESIVE DERMABOND OR POLYMER MESH TAPE DERMABOND. REPORTED COMPLICATION: SURGICAL SITE INFECTION ¿ (N-?). CONCLUSION LAYERED SKIN CLOSURE TECHNIQUE WITH SUBCUTICULAR CLOSURE AND CYANOACRYLATE ADHESIVE IS AT LEAST EQUIVALENT TO TRADITIONAL STAPLED SKIN CLOSURE AFTER OPEN AWR. NOTABLY, THIS IS TRUE DESPITE THE DEGREE OF WOUND CONTAMINATION. FURTHER, LAYERED SKIN CLOSURE REDUCES THE RISK OF SURGICAL SITE OCCURRENCES AND INFECTIONS WHICH REQUIRE PROCEDURAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545866 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.
    839561 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other