BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 19756647 · Received July 16, 2024

    Report

    Report Number
    2210968-2024-07289
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    January 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. H6 CLINICAL CODE: E2402 ¿ UNSPECIFIED COMPLICATIONS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CLARK, KELLY, & PALAMUTHUSINGAM, SPIGELIAN HERNIA: A MULTI SITE REVIEW OF OPERATIVE OUTCOMES OF SURGICAL REPAIR IN THE ADULT POPULATION, HERNIA (2024), HTTPS://DOI.ORG/10.1007/S10029-023-02946-1.

    Description of Event or Problem · 0

    TITLE: SPIGELIAN HERNIA: A MULTI-SITE REVIEW OF OPERATIVE OUTCOMES OF SURGICAL REPAIR IN THE ADULT POPULATION. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO OBSERVE OPERATIVE OUTCOMES FOR OPEN AND MINIMALLY INVASIVE REPAIR. BETWEEN 2010 TO 2020, A TOTAL OF 43 PATIENTS (25 MALE AND 18 FEMALE) WITH A MEAN AGE OF 66 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD SPIGELIAN HERNIAS USING LAPAROSCOPIC AND OPEN APPROACH WITH MESH (24 PATIENTS) OR SUTURE (19 PATIENTS) AS METHOD OF REPAIR ON A PUBLIC AND PRIVATE SETTING. A PHYSIOMESH (ETHICON) WAS USED ON 8 PATIENTS, ULTRAPRO (ETHICON) ON 3 PATIENTS, PROLENE MESH ON 3 PATIENTS, COMPETITOR PRODUCTS FOR 3 PATIENTS, AND NOT STATED ON 4 PATIENTS. WHILE A PDS WAS USED ON 2 PATIENTS, VICRYL ON 1 PATIENT, COMPETITOR PRODUCTS ON 2 PATIENTS, AND NOT STATED ON 14 PATIENTS. ALL PATIENTS WERE FOLLOWED UP TO UNTIL 1 YEAR. REPORTED COMPLICATIONS INCLUDE: UNSPECIFIED COMPLICATIONS ON (N=2) WITH PROLENE MESH, HERNIAL RECURRENCE ON (N=1) WITH ULTRAPRO MESH, HERNIAL RECURRENCE ON (N=1) WITH PROLENE MESH, AND UNSPECIFIED COMPLICATIONS ON (N=1) WITH PDS SUTURE. CONCLUSION ALTHOUGH A SMALL SAMPLE SIZE, THE DATA SUGGEST THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN OPERATIVE OUTCOMES, COMPLICATION RATE AND PREDISPOSING FACTORS BETWEEN OPEN AND MINIMALLY INVASIVE CASE GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509379 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other