BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD2

    MDR report key: 15549370 · Received October 6, 2022

    Report

    Report Number
    9611423-2022-00036
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    May 12, 2022
    Report Date
    October 6, 2022
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    UDI-DI
    37290115921435
    PMA / PMN Number
    K192866
    Removal / Correction Number
    Z-1057-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PRODUCT COMPLAINT HAS BEEN ISSUE FOR THE DEFECTIVE ITEM. ITEM 412143 7 CS. DESCRIPTION: ITEM LEAKING. CUSTOMER OPEN 1CS AND USED THE 1BX ( 2BX/CS ) BUT 1BX WAS LEAKING. THEY STOPPED USING THE ENTIRE ORDER ( 7CS ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151087 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown