BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERLANE-L INJECTABLE GEL

    MDR report key: 1918084 · Received December 1, 2010

    Report

    Report Number
    2032896-2010-00042
    Event Type
    Other
    Date Received
    December 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, A SPONTANEOUS REPORT WAS RECEIVED FROM A MALE PHYSICIAN (AGE NOT REPORTED) WHO EXPERIENCED AN ACCIDENTAL EXPOSURE WHILE INJECTING A PT WITH PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). ON AN UNK DATE, THE PHYSICIAN WAS INJECTING A PT WITH PERLANE-L USING A 29 GAUGE NEEDLE WITH A PINK HUB. DURING THE IMPLANTATION OF PERLANE-L, THE NEEDLE DISENGAGED AND THE PRODUCT SHOT OUT, RESULTING IN THE PHYSICIAN GETTING THE PRODUCT INTO HIS EYE. THE PHYSICIAN'S BLINK REFLEX WAS AFFECTED AND THE LIDOCAINE CAUSED HIS EYE TO FEEL NUMB. THE PHYSICIAN CONSULTED AN OPHTHALMOLOGIST AND WAS TOLD "IT SHOULDN'T BE AN ISSUE." THE PHYSICIAN'S SYMPTOMS HAVE SINCE RESOLVED. THE LOT NUMBER AND EXPIRATION DATE WERE 10463-1 AND JUL-2011, RESPECTIVELY. THE PHYSICIAN ALSO REPORTED INFORMATION REGARDING TWO ADDITIONAL ACCIDENTAL EXPOSURES WHICH OCCURRED DURING AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) ((B)(4) AND (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERLANE-L INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB 10463-1

    Patients

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