BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP UNKNOWN PRODUCT

    MDR report key: 17513951 · Received August 11, 2023

    Report

    Report Number
    2210968-2023-05835
    Event Type
    Injury
    Date Received
    August 11, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS COMPLAINT WAS IDENTIFIED THROUGH THE CLINICAL EVALUATION REPORT (CER) PROCESS. THE CER PROCESS IS CONDUCTING A RETROSPECTIVE LITERATURE REVIEW FOR THE LIFE OF THE PRODUCT AND IN SOME CASES IDENTIFYING COMPLAINTS IN ARTICLES THAT CANNOT BE REASONABLY INVESTIGATED DUE TO THE AGE OF THE ARTICLE. ADDITIONALLY, 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. RELATED EVENT CAPTURED VIA 2210968-2023-05836.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING ELECTIVE UNILATERAL INGUINAL HERNIA REPAIR IN OPEN PROCEDURES. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: SS = SECURESTRAP, SSO = SECURESTRAP OPEN. PERIOPERATIVE AND 1-YEAR FOLLOW-UP OUTCOMES INTRAOPERATIVE COMPLICATIONS: TOTAL 1: ORGAN INJURIES SSO 1, VASCULAR SSO 1. GENERAL COMPLICATIONS: TOTAL 1: OTHERS SS 1. POSTOPERATIVE COMPLICATIONS: TOTAL 3: , BLEEDING SS 3. COMPLICATION-RELATED REOPERATIONS: SS 3. RECURRENCE, PAIN AND COMPLICATIONS ON 1-YEAR FOLLOW-UP: PAIN ON EXERTION SS 3, SSO 3, PAIN REQUIRING TREATMENT SS 1, TROCAR HERNIA SSO 1, SECONDARY HAEMORRHAGE SSO 1, SEROMA SS 1, INFECTION SSO 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217641 SECURESTRAP UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention