BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILESTONE DELTA

    MDR report key: 18383990 · Received December 21, 2023

    Report

    Report Number
    MW5149477
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    October 9, 2023
    Report Date
    December 19, 2023
    Manufacturer
    MILESTONE S.R.L.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DELTA TISSUE PROCESSOR MALFUNCTION LEADING TO DAMAGED SPECIMENS RESULTING IN NO DIAGNOSIS ACHIEVABLE FOR DIAGNOSTIC BIOPSIES. REPEAT BIOPSY AND ADDITIONAL MONITORING NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263965 MILESTONE DELTA PROCESSOR, TISSUE, AUTOMATED IEO MILESTONE S.R.L. 4

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Prefer Not To Disclose Required Intervention