BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DERMAL FILLER

    MDR report key: 14854483 · Received June 29, 2022

    Report

    Report Number
    3005113652-2022-00393
    Event Type
    Injury
    Date Received
    June 29, 2022
    Report Date
    June 29, 2022
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED IN CK 1, CK 4 AND CK 3 AREA, ON THE ZYGOMATIC BONE, LATERAL CHEEK AREA AND CHIN AREA WITH [UNSPECIFIED] DERMAL FILLER. PATIENT HAD A SWOLLEN BLOOD VESSEL ABOVE THE ZYGOMATIC AREA. PATIENT WAS TREATED WITH HYALASE THE AFFECTED AREA DUE TO A SUSPECTED PRESSURE ON THE VESSEL. THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379238 UNK DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R