BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 21306944 · Received February 4, 2025

    Report

    Report Number
    2210968-2025-01334
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    April 20, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. 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? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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/10.1007/S10029-024-03033-9.

    Description of Event or Problem · 0

    TITLE: OPEN INTRAPERITONEAL ONLAY MESH REPAIR WITH ANTERIOR COMPONENT SEPARATION AS A BAIL-OUT PROCEDURE IN THE MANAGEMENT OF COMPLEX HERNIAS. THE AIM OF THIS STUDY IS TO ASSESS THE SHORT- AND LONG-TERM COMPLICATIONS AFTER OPEN INTRAPERITONEAL ONLAY MESH (IPOM) REPAIR COMBINED WITH BILATERAL ANTERIOR COMPONENT SEPARATION (ACS) FOR LARGE AND DIFFICULT INCISIONAL HERNIAS, ALONGSIDE EVALUATING HERNIA RECURRENCE RATES. THIS RETROSPECTIVE ANALYSIS UTILIZED DATA SOURCED FROM HOSPITAL ELECTRONIC HEALTH RECORDS AND A PROSPECTIVE DATABASE AT AN ACADEMIC TERTIARY REFERRAL CENTER. DATA COLLECTION WAS CARRIED OUT FROM PATIENTS OPERATED BETWEEN JANUARY 2006 AND DECEMBER 2017. BETWEEN JANUARY 2006 AND DECEMBER 2017, A TOTAL OF 45 PATIENTS (25 MALES AND 20 FEMALES) WITH A MEDIAN AGE OF 57 YEARS (RANGE 48¿65 YEARS) WERE TREATED. THE FOLLOWING COMPOSITE MESHES WERE USED: PROCEED® (ETHICON) IN 24 PATIENTS, PARIETEX COMPOSITE® (SOFRADIM) MESH IN 18 PATIENTS, SILPROMESH® (PETERS SURGICAL) IN 3 PATIENTS. REPORTED COMPLICATIONS: SURGICAL SITE INFECTION (N=?), HEMATOMA (N=?), SOFT TISSUE NECROSIS (N=?), WOUND DEHISCENCE (N=?), WOUND DEHISCENCE WITH MESH INFECTION (N=?), FASCIAL DISRUPTION (N=?), SEROMA (N=?), SEROMA WITH SURINFECTION (N=?), SEROMA WITH ENTEROCUTANEOUS FISTULA (N=?), HERNIA RECURRENCE (N=?). IN CONCLUSION, DESPITE A HIGH SSO RATE, APPLICATION OF THE OPEN IPOM TECHNIQUE WITH ACS COULD SERVE AS A VALUABLE RESCUE OPTION FOR MANAGING LARGE AND COMPLEX HERNIAS, WITH ACCEPTABLE HERNIA RECURRENCE RATES AT LONG-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060741 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention