BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

    MDR report key: 18611144 · Received January 30, 2024

    Report

    Report Number
    2210968-2024-00812
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    May 12, 2022
    Report Date
    January 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED, H6. HEALTH EFFECT - IMPACT CODE. 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. 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. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: 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
    414173 PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention