BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH UNKNOWN PRODUCT

    MDR report key: 18705824 · Received February 14, 2024

    Report

    Report Number
    2210968-2024-01384
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    August 8, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2023); 408:300. HTTPS://DOI.ORG/10.1007/S00423-023-02958-6. RELATED EVENTS CAPTURED VIA 2210968-2024-01384 AND 2210968-2024-01385.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC VS OPEN REPAIR FOR PRIMARY MIDLINE VENTRAL HERNIA: A PROSPECTIVE COHORT STUDY. THE AIM OF THIS SINGLE-CENTER PROSPECTIVE COHORT STUDY WAS TO EXAMINE DIFFERENT REPAIR TECHNIQUES IN PATIENTS WITH PRIMARY MIDLINE VENTRAL HERNIA (PMVH). A TOTAL OF 754 PATIENTS WHO UNDERWENT PMVH REPAIR BETWEEN (B)(6) 2006 AND (B)(6) 2015 WERE INCLUDED IN THE STUDY. OF THESE, 33 WITH OPEN-ASSISTED LAPAROSCOPIC SURGERY AND 2 WITH SINGLE-PORT REPAIR WERE EXCLUDED. OPEN REPAIR WITHOUT MESH, OPEN REPAIR WITH MESH, AND IPOM WERE PERFORMED IN 251 (132 WERE FEMALE; MEAN AGE OF 46.1 YEARS), 273 (87 WERE FEMALE; MEAN AGE OF 50.3 YEARS), AND 195 (82 WERE FEMALE; MEAN AGE OF 52.4 YEARS) PATIENTS, RESPECTIVELY. PATIENTS LOST TO FOLLOW-UP (N=65) WERE EXCLUDED FROM THE ANALYSIS OF LONG-TERM OUTCOMES AND PROPENSITY SCORE MATCHING (PSM). DIFFERENT MESHES HAVE BEEN USED DURING THE STUDY PERIOD WHICH INCLUDES THE FOLLOWING: BARD COMPOSIX, PROCEED, VENTRALEX, VENTRALIGHT, AND OTHER TYPES WHICH MAY INCLUDE PHYSIOMESH. SYSTEMATIC FOLLOW-UP WAS CONDUCTED 6 MONTHS AND 2 AND 5 YEARS POSTOPERATIVELY. REPORTED COMPLICATIONS INCLUDE SURGICAL SITE INFECTION: SUPERFICIAL AND DEEP (N=?), SEROMA (N=?), HEMATOMA (N=?), ILEUS (N=?), AND HERNIA RECURRENCE (N=?). IN CONCLUSION, IN PMVH, OPEN REPAIR WITH MESH IS ASSOCIATED WITH LOWER RECURRENCE COMPARED WITH OPEN REPAIR WITHOUT MESH AND IPOM. PAIN, POSTOPERATIVE COMPLICATIONS (EXCEPT FOR SEROMA), AND FUNCTIONAL STATUS ARE SIMILAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385867 PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention