BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19018693 · Received April 2, 2024

    Report

    Report Number
    3013682457-2024-00005
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    September 8, 2022
    Report Date
    April 2, 2024
    Manufacturer
    TURNCARE, INC.
    Product Code
    FNM
    UDI-DI
    00860001236453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED BASED ON A RETROSPECTIVE REVIEW (REFERENCE RCA # (B)(4)). INVESTIGATION WAS CONDUCTED ON THE REPORTED INFORMATION AND FROM THE DATA COLLECTED BY THE GUARDIAN DEVICE AVAILABLE AT THE TIME.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED ON (B)(6) 2022. TWO PRESSURE INJURIES WERE OBSERVED ON THE PATIENT. A SACRUM DTI EVOLVED TO A STAGE 3 INJURY ON (B)(6) 2022. A SACRUM UNSTAGEABLE WITH DTPI DEBRIDED ON (B)(6) 2022 TO A STAGE 4. EVALUATION OF GUARDIAN DATA NOTED NO INDICATIONS OF DEVICE MALFUNCTION OR SIGNIFICANT GAPS IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867394 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention