BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 8199422 · Received December 27, 2018

    Report

    Report Number
    3005113652-2018-01775
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 27, 2018
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    30888628000111
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER MW 5081438. ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL; THEREFORE, ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. THE EVENT OF "DYSPNEA" IS PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    RECEIVED VOLUNTARY MEDWATCH FROM US FOOD AND DRUG ADMINISTRATION. HEALTHCARE PROFESSIONAL REPORTED, ¿PATIENT UNDERWENT INJECTION OF LARYNGEAL CLEFT WITH INJECTION OF JUVÉDERM® ULTRA PLUS XC FOR ASPIRATION. PATIENT SUBSEQUENTLY DEVELOPED DIFFICULTY BREATHING AND STRIDOR POST OP, REQUIRING HIGH FLOW NASAL CANNULA SUPPORT AT AN UNSPECIFIED TIME LATER. PATIENT SUBSEQUENTLY REQUIRED ENDOTRACHEAL INTUBATION AT AN UNSPECIFIED TIME LATER.¿ NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040411 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H30LA80187 30888628000111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention