BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SURGE CARDIOVASCULAR

    MDR report key: 20765590 · Received November 22, 2024

    Report

    Report Number
    3017540705-2024-00002
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    GCX
    UDI-DI
    00817278010514
    PMA / PMN Number
    K971022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER A BOX CONTAINED UNSEALED POUCHES AT THE BOTTOM. THIS WAS IDENTIFIED PRIOR TO USE. NO INJURY/DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852367 SURGE CARDIOVASCULAR RIGID INTRACARDIAC SUCKER GCX MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR SUC-4300S 08294-080724 00817278010514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown