BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE

    MDR report key: 13585632 · Received February 9, 2022

    Report

    Report Number
    13585632
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    January 16, 2021
    Report Date
    March 26, 2021
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021 PATIENT WITH HEARTWARE DRIVELINE WITH MULTIPLE FRACTURES. HEARTWARE REPLACED WITH HEARTMATE III.

    Description of Event or Problem · 0

    ON (B)(6) 2021 PATIENT WITH HEARTWARE DRIVELINE WITH MULTIPLE FRACTURES. HEARTWARE REPLACED WITH HEARTMATE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108585 HEARTWARE LEFT VENTRICULAR ASSIST DEVICE DSQ

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Hospitalization| R