BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP UNKNOWN PRODUCT

    MDR report key: 23730055 · Received December 5, 2025

    Report

    Report Number
    2210968-2025-13645
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    July 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: BR J SURG. 2025 SEP 2;112(9):ZNAF169. DOI: 10.1093/BJS/ZNAF169. PMID: 40893041; PMCID: PMC12404345. HTTPS://DOI.ORG/10.1093/BJS/ZNAF169.

    Description of Event or Problem · 0

    RECURRENCE RATE AND MESH BULGING ARE REDUCED WITH PRIMARY FASCIAL CLOSURE IN VENTRAL HERNIA REPAIR: THE PROSECO RANDOMIZED CLINICAL TRIAL. THIS RANDOMIZED, PARALLEL, DOUBLE-BLIND, MULTICENTRE CONTROLLED TRIAL INVESTIGATED WHETHER PRIMARY FASCIAL CLOSURE REDUCES HERNIA SITE COMPLICATIONS. NOVEMBER 2015 TO SEPTEMBER 2020, A TOTAL OF 192 PATIENTS WERE ENROLLED IN THE STUDY, OF WHICH 97 WERE RANDOMIZED TO THE FASCIAL CLOSURE GROUP AND 95 TO THE NON-CLOSURE GROUP. THE PROSTHETIC MESH WAS FIXED WITH A RESORBABLE TACKER SECURESTRAP® (SS; ETHICON US, LLC, ETHICON, INC., SOMERVILLE, NJ, USA) IN A DOUBLE-CROWN MANNER. PORT SITES >5 MM WERE CLOSED WITH SLOWLY RESORBABLE POLYDIOXIANE (PDS 2.0, (SS; ETHICON US, LLC, ETHICON, INC., SOMERVILLE, NJ, USA)). REPORTED COMPLICATIONS ARE: SECURESTRAP® (SS; ETHICON US, LLC, ETHICON, INC., SOMERVILLE, NJ, USA); PDS 2.0, (SS; ETHICON US, LLC, ETHICON, INC., SOMERVILLE, NJ, USA). N=? SEROMA, TREATMENT: NOT REPORTED. N=? RECURRENCE, TREATMENT: NOT REPORTED. N=? INFECTION, TREATMENT: NOT REPORTED. N=? MESH BULGING, TREATMENT: NOT REPORTED. N=4 PORT SITE HERNIA, TREATMENT NOT REPORTED. N=1 MECHANICAL INTESTINAL OBSTRUCTION IN THE EARLY POSTOPERATIVE PERIOD, TREATMENT: REOPERATION'. N=1 INADVERTENT COLONIC PERFORATION, TREATMENT: REOPERATION. IN CONCLUSION, THIS IS THE FIRST STUDY TO PROVIDE HIGH-QUALITY EVIDENCE THAT CLOSURE OF THE HERNIA DEFECT BEFORE MESH PLACEMENT IN LAPAROSCOPIC IPOM REDUCES THE RATE OF RECURRENCE/MESH BULGING. FURTHERMORE, AT THE 1-YEAR FOLLOW-UP THE CLOSURE GROUP REPORTED SIGNIFICANTLY LESS PAIN THAN THE NON-CLOSURE GROUP. TAKEN TOGETHER, THESE FINDINGS STRONGLY SUPPORT RESTORATION OF THE ABDOMINAL WALL USING NON-RESORBABLE SUTURES PRIOR TO MESH PLACEMENT IN IPOM HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2884524 SECURESTRAP UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention