BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERLANE, PERLANE

    MDR report key: 4008007 · Received August 4, 2014

    Report

    Report Number
    2032896-2014-00597
    Event Type
    Injury
    Date Received
    August 4, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2014. LYMPHADENOPATHY, EYE INFECTION, NEUROLOGICAL INFECTION, HEADACHE, BLISTER, CALCINOSIS, MALAISE ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON JULY 3, 2014 FROM A CONSUMER AND CONCERNS A FEMALE PATIENT. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE 2 YEARS AGO, THE PATIENT STARTED TREATMENT WITH PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) INJECTION FOR A COSMETIC PROCEDURE. THE BATCH NUMBER USED WAS NOT REPORTED. ON THE DAY AFTER THE INJECTION, SHE BECAME SICK WITH SIDE EFFECTS INCLUDING LYMPH NODE INFLAMMATION, INFECTION OF EYES AND NERVE, HEADACHES, BLISTERS ON EYE, AND CALCIUM DEPOSITS. SHE STATED THAT SHE WAS "IN AND OUT OF HOSPITALS." THE PATIENT ALSO INQUIRED ABOUT SIDE EFFECTS OF THE PRODUCT AND THE PATIENT WAS INSTRUCTED TO CONTACT HER PHYSICIAN FOR FURTHER FOLLOW-UP. THE PATIENT DID NOT KNOW WHETHER SHE WAS INJECTED WITH PERLANE OR PERLANE L. SHE DECLINED TO PARTICIPATE IN THE ADVERSE EVENT REPORTING AND HENCE NO OTHER INFORMATION COULD BE OBTAINED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453592 PERLANE, PERLANE INJECTABLE DERMAL FILLER LMH MEDICIS AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization