BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERLANE INJECTABLE GEL

    MDR report key: 2083112 · Received April 29, 2011

    Report

    Report Number
    2032896-2011-00028
    Event Type
    Other
    Date Received
    April 29, 2011
    Report Date
    April 21, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(4)-2011, A SPONTANEOUS REPORT VIA AN E-MAIL WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE WHO RECEIVED AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PT REPORTED "I GOT PRE CANCEROUS LESIONS FROM PERLANE." NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. THE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PREV MEDS = UNK| CON MEDS = UNK