BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 18707134 · Received February 14, 2024

    Report

    Report Number
    2210968-2024-01388
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    December 31, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: THE AMERICAN JOURNAL OF SURGERY, HTTPS://DOI.ORG/10.1016/J.AMJSURG.2023.12.032 RELATED EVENTS CAPTURED VIA 2210968-2024-01387, AND 2210968-2024-01389.

    Description of Event or Problem · 0

    TITLE: AGE IS JUST A NUMBER: THE ROLE OF ADVANCED AGE IN PREDICTING COMPLICATIONS FOLLOWING VENTRAL HERNIA REPAIR WITH COMPONENT SEPARATION THIS STUDY AIMS TO ASSESS THE INFLUENCE OF ADVANCED AGE ON SHORT AND LONG-TERM POSTOPERATIVE COMPLICATIONS FOLLOWING VENTRAL HERNIA REPAIRS WITH COMPONENT SEPARATION TECHNIQUE TO BETTER INFORM DECISIONS REGARDING SURGICAL CANDIDACY, PREOPERATIVE COUNSELING, AND POSTOPERATIVE MANAGEMENT. BETWEEN (B)(6) 2008 TO (B)(6) 2022, 219 PATIENTS WHO UNDERWENT VENTRAL HERNIA REPAIRS WITH COMPONENT SEPARATION TECHNIQUE WERE INCLUDED IN THE STUDY. THERE WERE 103 MALES AND 116 FEMALES WITH A MEAN AGE OF 59.1 +/- 11.3 YEARS AND A MEAN BMI OF 31.7 KG/M2. THERE WERE 114 PATIENTS WHO WERE AGED 60 YEARS AND ABOVE. A VARIETY OF MESH TYPES, INCLUDING A COMPETITOR BIOLOGIC MESH (MANUFACTURER: LIFECELL CORP.), COMPETITOR COMPOSITE MESH (MANUFACTURER: C.R. BARD, INC.), PROCEED COMPOSITE MESH (ETHICON) OR VICRYL SYNTHETIC MESH (ETHICON) WERE INCORPORATED INTRAPERITONEALLY AND SECURED USING PDS SUTURES (ETHICON). THE PREDOMINANT MESH TYPE WAS A COMPETITOR BIOLOGIC MESH UNTIL 2018 WHEN THE USE OF COMPETITOR COMPOSITE MESH BECAME EQUALLY COMMON. REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION/CELLULITIS (N=14), ABSCESS (N=8), SEROMA (N=?), HEMATOMA (N=2), HERNIA RECURRENCE (N=16), ABDOMINAL FLUID COLLECTIONS (N=?), SMALL BOWEL OBSTRUCTION (N=6), EVENTS CAUSING RETURN TO OPERATING ROOM (N=15). IN CONCLUSION, VENTRAL HERNIA REPAIRS WITH COMPONENT SEPARATION TECHNIQUE IS GENERALLY SAFE TO PERFORM IN PATIENTS OF ADVANCED AGE. EVERY PATIENT'S COMORBIDITY PROFILE SHOULD BE THOROUGHLY ASSESSED PREOPERATIVELY FOR RISK STRATIFICATION REGARDLESS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225154 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention