BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 3052950 · Received April 5, 2013

    Report

    Report Number
    3005113652-2013-00038
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    July 15, 2012
    Report Date
    March 11, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2013. ALLERGAN HAS REQUESTED FURTHER INFO REGARDING THIS EVENT SUCH AS THE LOT NUMBER OF THE DEVICE. TO DATE NO ADD'L INFO HAS BEEN RECEIVED. DEVICE LABELING: ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER INJECTION IN THE TEAR TROUGHS WITH "2.5 OR 3" SYRINGES OF JUVEDERM THE PATIENT EXPERIENCED "AN EXPLOSION OF BUMPS" BETWEEN THE EYES AND IN THE TEAR TROUGHS SIX MONTHS LATER. THE PATIENT WAS TREATED BY THE INJECTING PHYSICIAN WITH "AN ANTISERUM" THAT THE PATIENT BELIEVES WAS HYALURONIDASE. ADD'L TREATMENT INCLUDED A "CORTISONE" INJECTION IN THE FOREHEAD WHICH ALLEVIATED THE SYMPTOMS FOR 6 MONTHS. PATIENT CURRENTLY EXPERIENCING SYMPTOMS OF SWELLING "IN THE TEAR DUCTS", PUFFINESS IN THE LIPS, AND A "HOLLOW" IN THE CHEEK. PATIENT RECENTLY WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED PREDNISONE. SYMPTOMS HAVE NOT YET RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139903 JUVEDERM (VOLUME/CONCENTRATION UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention LEVOXYL