BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TERUMO CARDIOVASCULAR

    MDR report key: 17013730 · Received May 26, 2023

    Report

    Report Number
    3017540705-2023-00001
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 26, 2023
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    GCX
    UDI-DI
    00817278011399
    PMA / PMN Number
    K971022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER A POUCH WAS UNSEALED 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
    1768676 TERUMO CARDIOVASCULAR RIGID INTRACARDIAC SUCKER GCX MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR 4300S 06217-113022 00817278011399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown