BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP ACTIVFLO BIOPSY III, TAPED BLUE

    MDR report key: 20055427 · Received August 23, 2024

    Report

    Report Number
    1419341-2024-00010
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 23, 2024
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    IDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. A CUSTOMER RETURN WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED IP ACTIVFLO BIOPSY III, TAPED BLUE, P/N 39LC-625-2-L, LOT 231220-A WAS DEFORMED CAUSING THE CASSETTE TO NOT STAY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618584 IP ACTIVFLO BIOPSY III, TAPED BLUE CASSETTES, TISSUE IDZ LEICA BIOSYSTEMS IP ACTIVFLO BIOPSY III, TAPED BLUE 231220-A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown