BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 4170543 · Received October 9, 2014

    Report

    Report Number
    3005113652-2014-00508
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    February 22, 2011
    Report Date
    September 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF A VASCULAR EVENT WITH ASSOCIATED NECROSIS; "RETICULATED AND EDEMATOUS PURPURIC PLAQUE"; ERYTHEMA; AND PURPURA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IN THE ARTICLE "IMPENDING NECROSIS AFTER INJECTION OF HYALURONIC ACID AND CALCIUM HYDROXYLAPATITE FILLERS: REPORT OF 2 CASES TREATED WITH HYPERBARIC OXYGEN THERAPY," DARLING, MELISSA D.: PETERSON, JENNIFER D.; FABI, SABRINA G. DERMATOLOGIC SURGERY, (2014 SEPTEMBER) VOL. 40, NO. 9, PP. 1049-1052, THE AUTHORS DESCRIBE TWO CASE STUDIES, EACH INVOLVING "IMPENDING NECROSIS AND ACTIVE NECROSIS" DUE TO "INJURY OF A VESSEL, COMPRESSION OF THE AREA AROUND THE VESSEL, OR INTRAVASCULAR OBSTRUCTION OF THE VESSELS BY FILLER MATERIAL." THESE CASES WERE "SUCCESSFULLY MANAGED" WITH THERAPIES INCLUDING HYPERBARIC OXYGEN THERAPY (HBOT). THIS RECORD CAPTURES CASE 2: A PATIENT UNDERWENT INJECTION OF 1 ML OF JUVEDERM ULTRA XC IN THE NASOLABIAL FOLDS. THE DAY FOLLOWING INJECTION THE PATIENT "PRESENTED WITH A PAINLESS, RETICULATED, AND EDEMATOUS PURPURIC PLAQUE ON THE LEFT SIDE OF [THEIR] FACE, WHICH EXTENDED FROM [THEIR] NASAL TIP, ALONG THE NASAL ALA, NLF, AND UPPER CUTANEOUS LIP. EXAMINATION ALSO REVEALED AN EROSION (10 X 7 MM) AT THE MIDPOINT OF [THEIR] LEFT NLF, BILATERAL EDEMA OF [THEIR] NLFS (GREATER ON THE LEFT), AND NORMAL SENSATION." THE PATIENT WAS TREATED WITH "WARM COMPRESSES, MUPIROCIN 2% OINTMENT," AND A VITRASE INJECTION "TO THE SUPERIOR ASPECT OF THE LEFT NLF. OVERNIGHT, [THE PATIENT] USED OXYGEN 2 L PER MINUTE BY NASAL CANNULA, APPLIED PETROLATUM OINTMENT EVERY 2 HOURS, AND TOOK ASA (325 MG) AND IBUPROFEN (400 MG EVERY 4 HOURS). ON POST-INJECTION DAY 2, EXAMINATION REVEALED DECREASED EDEMA BILATERALLY, DECREASED ERYTHEMA OF THE NOSE, AND DECREASED PURPURA OF THE LEFT NLF; HOWEVER, THE EROSION HAD MINIMAL IMPROVEMENT. TO LIMIT THE SPREAD OF TISSUE LOSS, THE PATIENT WAS TREATED WITH 2 DIVES OF HBOT [HYPERBARIC OXYGEN THERAPY], ONE EACH ON BOTH DAYS 3 AND 4." SIX DAYS AFTER INJECTION "THE PURPURA, ERYTHEMA, AND EROSION HAD RESOLVED WITH NO RESIDUAL COSMETIC DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636860 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24L617620

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention TOPAMAX| NEXIUM| CYMBALTA| TRIAMTERENE