BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1218887 · Received October 31, 2008

    Report

    Report Number
    9710154-2008-00020
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    August 2, 2008
    Report Date
    October 28, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)# P040024.

    Description of Event or Problem · 1

    INFO WAS RECEIVED REGARDING A (B) (6) FEMALE PT WHO RECEIVED AN INJECTION OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) ON (B) (6) 2008, TO THE AREA UNDER BOTH EYES. ANESTHESIA IN THE FORM OF AN UNSPECIFIED NUMBING CREAM WAS USED PRE-PROCEDURE. MEDICAL HISTORY INCLUDED ALLERGY TO HORSES. THE PT TOOK NO CONCOMITANT MEDICATIONS. ON (B) (6) 2008, THE PT DEVELOPED DIFFICULTY BREATHING (DYSPNOEA) DESCRIBED AS COULD NOT TAKE DEEP BREATHS (QUICK AND SHALLOW BREATHING), SOMETIMES COULD NOT BREATH OUT, CHEST TIGHTNESS (CHEST DISCOMFORT), WHEEZING (WHEEZING), AND PAIN WITH INSPIRATION AND EXHALATION (PAINFUL RESPIRATION). THE PT REPORTED THESE "ATTACKS" COME AND GO; SHE MAY BE FINE FOR A FEW HRS AND THEN EXPERIENCE AN "ATTACK". TREATMENT INCLUDED PRIMATENE AND ALBUTEROL. THE PT REPORTED THE "ATTACK" TYPICALLY DOES NOT SUBSIDE UNTIL SHE USED ONE OF THE INHALERS. THE PT WENT ON VACATION IN (B) (6) OF 2008 AND THE SYMPTOMS IMPROVED. ON AN UNSPECIFIED DATE IN (B) (6) 2008, THE PT RECEIVED ANOTHER INJECTION OF RESTYLANE TO THE AREA UNDER BOTH EYES. ANESTHESIA IN THE FORM OF AN UNSPECIFIED NUMBING CREAM WAS USED PRE-PROCEDURE. THE PT REPORTED THE EVENTS WORSENED AFTER THE INJECTION (CONDITIONS AGGRAVATED). TREATMENT INCLUDED ZYRTEC AND ADVAIR. AS OF THE DATE OF THIS REPORT THE EVENTS WERE ONGOING. THE PATIENT PROVIDED ONLY ONE LOT NUMBER 9238-1 AND EXPIRATION DATE 04/2010. IT WAS UNKNOWN ON WHICH DATE THIS LOT NUMBER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9238-1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR