BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1378316 · Received May 8, 2009

    Report

    Report Number
    2032896-2009-00008
    Event Type
    Other
    Date Received
    May 8, 2009
    Date of Event
    April 27, 2009
    Report Date
    May 5, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/ 510(K): P020023. THE PA CHARACTERIZED THE "ODD, WEIRD" BRUISING BENEATH THE EYE AS "HAVING VASCULAR INVOLVEMENT." THE LOT NUMBER AND EXPIRATION DATE WERE 9561 AND 01/2011, RESPECTIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN ASSISTANT (PA) REGRADING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED PREVIOUS BOTOX (BOTULINUM TOXIN TYPE A) INJECTION, CHEMICAL PEELS, AND "OTHER PROCEDURES" (UNSPECIFIED) ALL WITHOUT ADVERSE SEQUELAE; THE PATIENT HAD NO KNOWN ALLERGIES. CONCOMITANT MEDICATIONS INCLUDED TOPAMAX (TOPIRAMATE), AMITRIPTYLINE, AND AN UNSPECIFIED MIGRAINE MEDICATION. DATES OF THERAPY AND DOSES WERE NOT REPORTED. ON (B)(6) 2009, THE PATIENT RECEIVED A 1 ML INJECTION OF RESTYLANE TO THE UPPER AND LOWER LIPS AND NASOLABIAL FOLDS. ANESTHESIA IN THE FORM OF TOPICAL PRILOCAINE AND LIDOCAINE WAS APPLIED AT HOME. TOPICAL ALCOHOL WAS USED BEFORE INJECTION. ON (B)(6) 2009, APPROXIMATELY 2 HOURS AFTER IMPLANTATION, THE PATIENT REPORTED AN "ODD BRUISE" DESCRIBED AS BRUISING IN THE AREA TOWARD THE EYE (BENEATH THE EYE, NOT AN AREA THAT HAD BEEN TREATED). THE PA HAD THE PATIENT COME BACK TO THE OFFICE AND DESCRIBED THE BRUISE AS "MOTTLING". TREATMENT INCLUDED MASSAGING, WARM COMPRESS TO THE AREA, AND BABY ASPIRIN. APPROXIMATELY 2 HOURS LATER THE PATIENT REPORTED MOTTLING CROSSED OVER THE EDGE OF HER NOSE. THE PATIENT RETURNED TO THE OFFICE THAT NIGHT AND THE PA INJECTED HYALURONIDASE. ON (B)(6) 2009, THE PATIENT REPORTED SIGNIFICANT LEFT NARE "RUNNING" (CLEAR FLUID) AND AGAIN RETURNED TO THE OFFICE. SOME "WHITENESS" WAS OBSERVED IN THE AREA OF BRUISING AND A DECISION WAS MADE TO FURTHER TREAT THE PATIENT IN A HYPERBARIC CHAMBER FOR 1 HOUR. ON (B)(6) 2009, THE PATIENT'S CONDITION HAD MODERATELY IMPROVED AND CONTINUED TO IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9561

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other AMITRIPTYLINE| MIGRAINE MEDICATION (UNSPECIFIED)| TOPAMAX (TOPIRAMATE)