BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP UNKNOWN PRODUCT

    MDR report key: 22607779 · Received July 25, 2025

    Report

    Report Number
    2210968-2025-08584
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ATTEMPTS ARE BEING 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: JSLS. 2025 JAN-MAR;29(1):E2024.00072. HTTPS://DOI.ORG/10.4293/JSLS.2024.00072 EPUB 2025 APR 1. PMID: 40171545; PMCID: PMC11960418.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, H1 - THIS MEDWATCH REPORT IS BEING VOIDED BASED ON RESPONSE RECEIVED CONFIRMING THE SURGEON DOES NOT BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE. ADDITIONALLY, THE SURGEON DOES NOT BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE.

    Description of Event or Problem · 0

    TITLE: SUTURELESS ""SLIM-MESH"" TECHNIQUE FOR THE REPAIR OF ABDOMINAL-WALL HERNIAS IN THE OBESE POPULATION. THIS STUDY AIMS TO REDUCE SURGICAL TIME AND INTRA- AND POSTOPERATIVE COMPLICATIONS. BETWEEN SEPTEMBER 2009 TO MAY 2023, 64 OBESE/SUPEROBESE VENTRAL-HERNIA PATIENTS UNDERWENT TREATMENT WITH THE SUTURELESS ¿SLIM-MESH¿ TECHNIQUE FOR THE REPAIR OF ABDOMINAL-WALL HERNIAS USING ETHICON ABSORBABLE SECURESTRAPS. REPORTED COMPLICATIONS ARE SECURESTRAPS N=4 WITH SEROMAS N=1 ABDOMINAL WALL PAIN TREATMENT: NOT REPORTED N=4 RECURRENCES OF A SYMPTOMATIC HERNIA (N=2 TROCAR-SITE) TREATMENT: REOPERATION (N=2). IN CONCLUSION, A NOVEL LAPAROSCOPIC SUTURELESS TECHNIQUE FOR VH REPAIR IN THE O/SO POPULATIONS, SIMPLIFIES THE MESH¿S INTRODUCTION INTO A 12-MM Ø-PORT, AS WELL AS ITS ORIENTING, HANDLING, AND FIXATION, BECAUSE THE SM IS SMALL, COMPACT AND EASILY MANIPULATED. FURTHERMORE, IT REQUIRES NO TRANSABDOMINAL FIXATION SUTURES OR EXPENSIVE ALTERNATIVES FOR MESH INTRODUCTION AND/OR FIXATION. THE SM TECHNIQUE IS SAFE, AS IT REDUCES MORBIDITY AND MORTALITY; IT ALSO ECONOMICAL, SIMPLE, FAST, EASY-TO-LEARN AND -REPRODUCE, EVEN WHEN TREATING VH O/SO CASES, INCLUDING THOSE WITH L-G AND M VH AND MWSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126134 SECURESTRAP UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention