BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA JARIT

    MDR report key: 19971513 · Received August 13, 2024

    Report

    Report Number
    19971513
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 12, 2024
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW INSTRUMENTS RECEIVED OUT OF THE PACKAGING WITH BROWN RUST LIKE STAINING AND BLACK SPOTS WHEN UNPACKAGED. THESE ARE BRAND NEW INSTRUMENTS OUT OF THE BOX PRIOR TO PROCESSING UPON ARRIVAL TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514217 INTEGRA JARIT HANDLE, SCALPEL GDZ INTEGRA LIFESCIENCES PRODUCTION CORPORATION 110178 AF2308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown