BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3131075 · Received May 21, 2013

    Report

    Report Number
    2032896-2013-00087
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 9, 2013
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE_COMMENT: (B)(4) 2013. THE EVENTS UPPER RESPIRATORY TRACT INFECTION (URTI), RUNNY ROSE, COLD SORES ON LIPS, LIP SWOLLEN AND PAINFUL LIP, AND LIP INFECTION ASSESSED AS SERIOUS, EXPECTED AND POSSIBLY RELATED. STYE, PUS IN LIP ASSESSED AS SERIOUS, EXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN AND CONCERNED ABOUT (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) WITH 0.3% LIDOCAINE. MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE AND HISTORY OF BREAST CANCER IN 2004. SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS INCLUDED AMLODIPINE AND XFORGE (AMLODIPINE AND VALSARTAN). THE PATIENT RECEIVED AN INJECTION OF RESTYLANE-L (VOLUME INJECTED AND SYRINGE SIZE NOT REPORTED) ON (B)(6) 2013 TO THE UPPER AND LOWER LIP. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. APPROXIMATELY 2 AND A HALF WEEKS AFTER THE RESTYLANE L INJECTION IN LIPS (BETWEEN (B)(6) 2013), THE PATIENT GOT SICK WITH AN UPPER RESPIRATORY TRACT INFECTION (URTI), WITH A STYE IN HER EYES, A RUNNY NOSE, AND COLD SORES ON HER LIPS. THE PATIENT WENT ON AN ANTIBIOTIC. A WEEK AFTER THAT, RIGHT UPPER LIP OF PATIENT GOT SWOLLEN AND PAINFUL (BETWEEN (B)(6) 2013). THE PATIENT WAS SWITCHED TO LEVOQUIN 500 MG 2 TIMES DAILY ORALLY, FOR 10 DAYS. THE PATIENT WAS ALSO PRESCRIBED VALTREX 1 GM 2 TIMES DAILY ORALLY FOR 1 WEEK, AND CIPROFLOXACIN 500 MG 2 TIMES DAILY ORALLY FOR 10 DAYS. THE PATIENT DEVELOPED SUPER INFECTED HERPES. ON LEVOQUIN, HER WHOLE UPPER LIP GOT REINFECTED, AND THE LOWER LIP GOT INFECTED AS WELL. THE PATIENT WAS INJECTED VITRASE TO HER UPPER AND LOWER LIP. THE PATIENT HAD LOCALIZED PUS IN HER UPPER LIP. THE PUS WAS DRAINED FROM PATIENT'S UPPER LIP AND CULTURED IT. THE CULTURE DID NOT GROW. THE PHYSICIAN WAS CONSULTING WITH INFECTIOUS DISEASES ON TREATING THE PATIENT. THE PHYSICIAN WAS SUSPECTING A BIOFILM INFECTION AND INJECTED MORE VITRASE TO HER UPPER AND LOWER LIP. THE PATIENT WAS BACK ON VALTREX X 1GM ORALLY 2 TIMES DAILY AND BIAXIN 500 MG ORALLY 2 TIMES DAILY FOR ONE MONTH. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE OUTCOME OF THE EVENT WAS NOT RECOVERED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4) ((B)(4) ON BEHALF OF VALEANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225668 RESTYLANE L, RESTYLANE LIDOCAINE INJECTABLE DERMAL FILLER LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention VALSARTAN)| AMLODIPINE (AMLODIPINE) (AMLODIPINE)| XFORGE (DIOVAN AMLO) (AMLODIPINE BESILATE,