BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGS

    MDR report key: 17993315 · Received October 23, 2023

    Report

    Report Number
    3010288205-2023-00001
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 7, 2023
    Manufacturer
    HANGZHOU AGS MEDTECH CO.,LTD.
    Product Code
    FCL
    UDI-DI
    20816734023123
    PMA / PMN Number
    N/AN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTAINMENTS WE HAVE ALREADY MADE: (1) AFTER VERIFYING THAT IT IS JUST A LABEL TEMPLATE ERROR, CORRECTED THE ERROR AND PRINT OUT THE PRODUCT LABEL CORRECTLY; (2)THE REMAINING PRODUCTS WITH INCORRECT LABELS WILL BE SCRAPED, AND THE COMPANY WILL COMPENSATE FOR THE CORRECTLY LABELED PRODUCTS.

    Description of Event or Problem · 0

    SYMBOL FOR SCOPE SIZE IS INCORRECT ON POUCH, CASE, AND BOX LABEL. LABEL FILE AND APPROVED LABELS ARE FOR 3.2MM, THE PRODUCT IN STOCK SHOWS 2.8MM SCOPE IN THE SYMBOL SECTION OF THE LABELS, BUT THE PRODUCTS SIZE ITSELF IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923284 AGS DISPOSABLE SWINGING BIOPSY FORCEPS FCL HANGZHOU AGS MEDTECH CO.,LTD. AG-50212-2823 0604669 20816734023123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention