BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HA DERMAL FILLER

    MDR report key: 3192907 · Received June 25, 2013

    Report

    Report Number
    2024601-2013-00584
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON (B)(4) 2013. INVESTIGATION INTO THE REPORTED ADVERSE EVENTS IS ONGOING; INFORMATION SUCH AS THE LOT NUMBER AND PRODUCT TYPE OF HYALURONIC ACID DERMAL FILLER ARE UNAVAILABLE AT THIS TIME. DEVICE LABELING: PRECAUTIONS FOR USE: AS A MATTER OF GENERAL PRINCIPLE, INJECTION OF A MEDICAL DEVICE IS ASSOCIATED WITH A RISK OF INFECTION. UNDESIRABLE EFFECTS: THE PATIENTS MUST BE INFORMED THAT THEY ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING OR PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. CASES OF NECROSES IN THE GLABELLAR REGION, ABSCESSES, GRANULOMA AND IMMEDIATE OR DELAYED HYPERSENSITIVITY AFTER HYALURONIC ACID AND/OR LIDOCAINE INJECTIONS HAVE BEEN REPORTED. IT IS THEREFORE, ADVISABLE TO TAKE THESE POTENTIAL RISKS INTO ACCOUNT. PATIENTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE. THE MEDICAL PRACTITIONER SHOULD USE AN APPROPRIATE TREATMENT. ANY OTHER UNDESIRABLE SIDE EFFECTS ASSOCIATED WITH INJECTION OF JUVEDERM ULTRA XC MUST BE REPORTED TO THE DISTRIBUTOR AND/OR TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IN THE ARTICLE "COMPLICATIONS OF DERMAL FILLERS - AN EXPERIENCE FROM MIDDLE-EAST", JOURNAL OF (B)(6) ASSOCIATION OF DERMATOLOGISTS (2012);22., THE AUTHORS DESCRIBE A TOTAL 47 CASES WHO WERE SEEN OVER A PERIOD OF 2 YEARS WITH VARIOUS COMPLICATIONS FROM DERMAL FILLERS. SEVEN OF THE FORTY-SEVEN CASES RESULTED AFTER THE USE OF HYALURONIC ACID DERMAL FILLERS. THOUGH SYMPTOMS AND TREATMENT WERE MENTIONED WITHIN THE ARTICLE, THE AUTHORS DID NOT SAY SPECIFICALLY WHAT ADVERSE EVENTS WERE EXPERIENCED BY EACH PATIENT, NOR THE CORRESPONDING TREATMENTS. SYMPTOMS REPORTED INCLUDED: CELLULITIS, TREATED WITH "MEDICAL MANAGEMENT INCLUDING ANTIBIOTIC, STEROIDS, REASSURANCE" (14 REPORTS); EDEMA/ALLERGY TREATED WITH STEROIDS, ANTIHISTAMINES" (9 REPORTS); ABSCESS TREATED WITH "OPEN/ULTRASOUND-GUIDED DRAINAGE" (9 REPORTS); GRANULOMA TREATED WITH "EXCISION" (6 REPORTS); RESIDUAL SCAR TREATED WITH "REASSURANCE/REVISION" (5 REPORTS); ASYMMETRY TREATED WITH "REASSURANCE" (4 REPORTS). FOLLOW UP WITH THE AUTHORS IS IN PROGRESS AND ALTHOUGH THE MANUFACTURER OF THE DEVICE IS UNKNOWN, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287922 UNK HA DERMAL FILLER LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention