BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TIDISHIELD EYESHIELD

    MDR report key: 20446696 · Received October 14, 2024

    Report

    Report Number
    2182318-2024-00119
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Report Date
    October 11, 2024
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    LYU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INCIDENT REPORT WAS IDENTIFIED WHILE REVIEWING THE CANADIAN MEDICAL DEVICE INCIDENTS DATABASE FOR THE PURPOSES OF ROUTINE POST MARKET SURVEILLANCE BY TIDI PRODUCTS FOR THE EYEWEAR PRODUCT FAMILY WHICH HAD NOT BEEN PREVIOUSLY CAPTURED IN OUR COMPLAINTS HANDLING SYSTEM. THE INCIDENT WAS NOT PREVIOUSLY REPORTED TO TIDI. BECAUSE THE COMPLAINT WAS IDENTIFIED VIA THE CANADIAN MEDICAL DEVICE INCIDENTS DATABASE, INFORMATION IS VERY LIMITED. HEALTH CANADA WAS CONTACTED BY THE MANUFACTURER FOR MORE INFORMATION, BUT NO ADDITIONAL INFORMATION WAS RECEIVED AS OF THE TIME OF THIS REPORT. HISTORICAL COMPLAINT DATA REVIEW WAS PERFORMED AND IDENTIFIED (B)(4) TOTAL COMPLAINTS IN THE LAST 2 YEARS FOR THIS PRODUCT FAMILY WHERE IT WAS REPORTED THAT THE PRODUCT WAS BREAKING AND/OR FALLING OFF. THIS PRODUCT FAMILY/FAILURE MODE HAS A COMPLAINT RATE OF (B)(4) OVER THIS TIME PERIOD BASED ON UNIT SALES. WITH THE INFORMATION PROVIDED, LITTLE INVESTIGATION CAN BE COMPLETED, AND THIS FAILURE MODE AND PRODUCT FAMILY HAS A VERY LOW COMPLAINT RATE OVER THE LAST 2 YEARS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).

    Description of Event or Problem · 0

    INCIDENT IDENTIFIED VIA REVIEW OF THE CANADIAN MEDICAL DEVICE INCIDENTS DATABASE: DEVICE FELL, DETACHMENT OF DEVICE OR DEVICE COMPONENT. EXPOSURE TO CONTAMINATED DEVISE, RISK OF INFECTION. INCIDENT ID (B)(4). THE INCIDENT DESCRIPTION ON THE DATABASE IDENTIFIES THE FOLLOWING CODES: F26 - NO HEALTH CONSEQUENCES OR IMPACT. F2303 - MEDICATION REQUIRED. F1007 - EXPOSURE TO CONTAMINATED DEVICE/RISK OF INFECTION. A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT. A051203 - DEVICE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319354 UNKNOWN TIDISHIELD EYESHIELD ACCESSORY, SURGICAL APPAREL LYU TIDI PRODUCTS LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown