BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH UNKNOWN PRODUCT

    MDR report key: 20785963 · Received November 26, 2024

    Report

    Report Number
    2210968-2024-12504
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    August 16, 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
    FR
    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? 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: J. CLIN. MED. 2023, 12, 5341. HTTPS://DOI.ORG/10.3390/JCM12165341.

    Description of Event or Problem · 0

    TITLE : PRIMARY VENTRAL HERNIA REPAIR AND THE RISK OF POSTOPERATIVE SMALL BOWEL OBSTRUCTION: INTRA VERSUS EXTRAPERITONEAL MESH. THE AIM OF THIS STUDY WAS TO COMPARE THE LIKELIHOOD OF BOWEL OBSTRUCTION ACCORDING TO THE POSITION OF THE MESH (EITHER INTRAPERITONEAL OR EXTRAPERITONEAL) IN A COHORT OF PATIENTS HAVING UNDERGONE UMBILICAL OR PERIUMBILICAL HERNIA REPAIR. BETWEEN MARCH 2008 AND JULY 2021, 440 PATIENTS WITH PRIMARY UMBILICAL OR PERIUMBILICAL HERNIAS WERE OPERATED ON AT THE UNIVERSITY HOSPITAL OF DIJON: 264 WITH AN OPEN APPROACH AND 176 BY LAPAROSCOPY. PATIENTS HAVING UNDERGONE A SIMPLE SUTURE OF THEIR HERNIA DEFECT WITHOUT USING A MESH (122 PATIENTS) WERE EXCLUDED, LEAVING A TOTAL OF 318 PATIENTS INCLUDED IN THIS STUDY. THE EP GROUP INCLUDED 99 PATIENTS, IN WHOM 71 MESHES WERE PLACED IN THE PREPERITONEAL PLANE AND 28 MESHES WERE PLACED IN THE RETRO MUSCULAR PLANE. THE IP GROUP INCLUDED 219 PATIENTS, WITH 175 PATIENTS OPERATED ON LAPAROSCOPICALLY, VERSUS 44 PATIENTS BY THE OPEN APPROACH. THE MESH USED WERE PROLENE, VICRYL , AND PHYSIOMESH. THE REPORTED COMPLICATIONS INCLUDED SEROMA (N=?), HEMATOMA (N=?), WALL INFECTION (N=?), BULGING (N=?), AND SMALL BOWEL PERFORATION/ INJURY (N=?). IN CONCLUSION, NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS FOUND IN TERMS OF BOWEL OBSTRUCTION BETWEEN THE INTRAPERITONEAL AND THE EXTRAPERITONEAL POSITION, BUT ALL CASES OF OBSTRUCTION HAPPENED IN THE INTRAPERITONEAL MESH GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384218 PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention