BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITEGUARD

    MDR report key: 20645073 · Received November 8, 2024

    Report

    Report Number
    3012271775-2024-00005
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    December 9, 2021
    Report Date
    February 4, 2025
    Manufacturer
    NEXT SCIENCE LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF CAPA 0032, A RETROSPECTIVE REVIEW WAS CONDUCTED TO ANALYZE THE FAILURE TO SUBMIT THIS MDR WITHIN THE REQUIRED 30-DAY TIMEFRAME. THE REVIEW IDENTIFIED INADEQUACIES IN THE COMPLAINT HANDLING PROCEDURE, INCLUDING THE ABSENCE OF STANDARDIZED DEFINITIONS FOR REPORTABLE EVENTS ALIGNED WITH FDA REGULATIONS. THIS LACK OF HARMONIZATION SIGNIFICANTLY CONTRIBUTED TO THE MISIDENTIFICATION OF THIS COMPLAINT AS A REPORTABLE MDR. ADDITIONALLY, THE COMPLAINT HANDLING UNIT DID NOT HAVE A STRUCTURED WORKFLOW TO GUIDE DECISION-MAKING WHEN INITIAL INFORMATION WAS INSUFFICIENT, FURTHER IMPACTING TIMELY AND ACCURATE REPORTING.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON AN EVENT FROM DECEMBER 2021. AN ANALYSIS OF THE DEVICE LOT RECORDS INDICATES THAT THE PRODUCT MET ALL SPECIFICATIONS AND RELEASE REQUIREMENTS. NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE AVAILABLE INFORMATION IN THE COMPLAINT FILE AND INVESTIGATION CONDUCTED BY NEXT SCIENCE, THERE IS NO CLEAR EVIDENCE TO REASONABLY SUGGEST THAT SITEGUARD MAY HAVE BEEN THE PRIMARY CAUSE OF THE REPORTED EVENT AND RESULTING HARM. OTHER MOST LIKELY FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDE (MAY NOT BE LIMITED TO) PATIENT SPECIFIC CONDITIONS (EG: COAGULOPATHIES OR ANTICOAGULANT USE) AND PROCEDURE SPECIFIC FACTORS (EG: AGGRESSIVE DEBRIDEMENT AND THE USE OF PROPHYLACTIC OR POINT OF USE HEMOSTATIC AGENTS) AND CONCOMITANT MEDICAL PRODUCTS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT RIGHT BREAST RECONSTRUCTION WITH A TISSUE EXPANDER. SURGIPHOR WAS APPLIED FIRST, FOLLOWED BY SITEGUARD. ARISTA WAS USED TO CONTROL BLEEDING. THE DOCTOR NOTED THAT STOPPING TO ENSURE BLEEDING WAS FULLY CONTROLLED ADDED TIME TO THE PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT RIGHT BREAST RECONSTRUCTION WITH A TISSUE EXPANDER. SURGIPHOR WAS APPLIED FIRST, FOLLOWED BY SITEGUARD. ARISTA WAS USED TO CONTROL BLEEDING. THE DOCTOR NOTED THAT STOPPING TO ENSURE BLEEDING WAS FULLY CONTROLLED ADDED TIME TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110852 SITEGUARD WOUND IRRIGATION SOLUTION FRO NEXT SCIENCE LLC YH069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SURGIHOR| SURGIHOR