BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP OPEN UNKNOWN PRODUCT

    MDR report key: 17461349 · Received August 4, 2023

    Report

    Report Number
    2210968-2023-05634
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K123114
    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 EVENTS CAPTURED VIA 2210968-2023-05633.

    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 OPEN INCISIONAL HERNIA REPAIR PROCEDURES. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: SECURESTRAP = SS, SECURESTRAP OPEN = SSO. INTRAOPERATIVE COMPLICATIONS TOTAL SS 20, SSO 11. BLEEDING SS 1, ORGAN INJURIES SS 19, SSO 11, BOWEL SS 16, SSO 10, BLADDER SS 1, STOMACH SS 1, LIVER SS 1, OTHERS SS 1, SSO 2. GENERAL COMPLICATIONS TOTAL SS 55, SSO 25. FEVER SS 5, SSO 2, URINARY TRACT INFECTION SS 11, SSO 3, DIARRHEA SS 2, SSO 2, THROMBOSIS SS 1, SSO 1, PULMONARY EMBOLISM SS 4, SSO 4, PLEURAL EFFUSION SS 1, SSO 1, PNEUMONIA SS 8, SSO 7, COPD SS 2, SSO 3, CARDIAC INSUFFICIENCY SS 2, RENAL INSUFFICIENCY SS 4 SSO 2, HYPERTENSIVE CRISIS SS 2, SSO 1, OTHERS SS 27, SSO 7. POSTOPERATIVE TOTAL SS 83, SSO 46. BLEEDING SS 21, SSO 11, SEROMA SS 34, SSO 15, PROLONGED ILEUS OR OBSTRUCTION SS 8, SSO 5, BOWEL INJURY/ANASTOMOTIC INSUFFICIENCY SS 4, SSO 2, WOUND HEALING DISORDER SS 28, SSO 17, INFECTION SS 14, SSO 4. COMPLICATIONS RELATED TO REOPERATIONS SS 39, SSO 28. RECURRENCE, PAIN AND COMPLICATIONS ON 1 YEAR FOLLOW UP - RECURRENCE SS 52, SSO 32, PAIN ON EXERTION SS 164, SSO 98, PAIN AT REST SS 98, SSO 57, PAIN REQUIRING TREATMENT SS 75, SSO 39, TROCAR HERNIA SSO 1, SECONDARY HAEMORRHAGE SS 8, SSO 8, SEROMA SS 58, SSO 19, INFECTION SS 32, SSO 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811909 SECURESTRAP OPEN UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention