BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 834603 · Received March 29, 2007

    Report

    Report Number
    9710154-2007-00004
    Event Type
    Other
    Date Received
    March 29, 2007
    Date of Event
    March 22, 2007
    Report Date
    March 22, 2007
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K) #P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT IS BEING SUBMITTED AS A 10-DAY REPORT. A NURSE REPORTED THAT A FEMALE PT REC'D INJECTIONS OF RESTYLANE INTO THE VERMILLION BORDER IN 2007. "TRIPLE CAINE" WAS APPLIED AS AN ANESTHETIC PRE-PROCEDURE. ADD'L PROCEDURES PERFORMED AT THE TIME OF RESTYLANE TREATMENT INCLUDED BOTOX (BOTULINUM TOXIN TYPE A) INJECTIONS INTO THE PERIORAL AREA. CONCURRENT MEDICAL CONDITIONS INCLUDED POSSIBLE ALLERGY TO LIDOCAINE. THE PT WAS NOT TAKING CONCOMITANT MEDICATIONS. PRIOR TO THE EVENT DATE, APPROX 10 MINS POST-PROCEDURE, THE PT FELT FAINT (DIZZINESS), BECAME "BREATHLESS" (DYSPNEA), AND LOST CONSCIOUSNESS (LOSS OF CONSCIOUSNESS) FOR 3 MINS. EMERGENCY MEDICAL SERVICES WERE DISPATCHED, AND THE PT WAS TREATED WITH OXYGEN. THE PT REFUSED EVAL AT A HOSP, AND SHE LEFT THE TREATMENT FACILITY ALERT. THE LOT NUMBER AND EXP DATE WERE REPORTED AS 7949-1 AND 3/2009, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LNM Q-MED AB NI 7949-1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR