BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET - AP406

    MDR report key: 13869107 · Received March 23, 2022

    Report

    Report Number
    3010293992-2022-00006
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 3, 2022
    Manufacturer
    EITAN MEDICAL LTD
    Product Code
    FPA
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME (B)(4).

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME 3010293992.

    Description of Event or Problem · 0

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6): DELIVERY ISSUE.

    Description of Event or Problem · 0

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE: DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924059 ADMINISTRATION SET - AP406 ADMINISTRATION SET FPA EITAN MEDICAL LTD 0164.1404.11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown