BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE LIPS+ 1.2 ML

    MDR report key: 17882309 · Received October 5, 2023

    Report

    Report Number
    3004423487-2023-00036
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 5, 2023
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING IS A CLINICAL OPINION BASED ON A CUSTOMER PRODUCT COMPLAINT. THIS IS NOT A CLINICAL ADVERSE REPORT EVENT. THE ONLY HISTORY PROVIDED IS AS FOLLOWS " AS INJECTOR WAS INJECTING, THE GEL WAS VISUALLY SEPARATED BY AN AIR BUBBLE AND THE PLUNGER WAS NOT ABLE TO PUSH THROUGH THE NEEDLE ". THE ONE PHOTO PROVIDED SHOWS A SYRINGE WITH .35 CC OF PRODUCT DISTALLY AT THE HUB AND THE PLUNGER COMPLETELY REMOVED FROM THE SYRINGE. THE SYRINGE HAS A 30 GAUGE NEEDLE ATTACHED. THE MOST COMMON REASON FOR AIR BUBBLES DURING INJECTION IS FROM ASPIRATION IN THE SETTING OF A NEEDLE THAT HAS NOT BEEN SECURELY SEATED ON THE HUB. THIS ALLOWS AIR TO ENTER THE SYRINGE FROM THE SEAL BETWEEN NEEDLE BASE AND SYRINGE HUB DURING ASPIRATION, WHICH IS PRACTISED BY MOST INJECTOR AS A CHECK THAT THE NEEDLE IS NOT INTRAVASCULAR. PROPER SECURING OF THE NEEDLE TO THE SYRINGE PREVENTS THIS FROM HAPPENING. INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246204 REVANESSE LIPS+ 1.2 ML REVANESSE LIPS+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40149 23B084 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown