BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE /00567501/

    MDR report key: 3212745 · Received July 3, 2013

    Report

    Report Number
    2032896-2013-00233
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 3, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013: THE EVENT SWELLING AT THE INJECTION SITES, FEELING ILL, ALLERGIC REACTION AND UNABLE TO SHUT EYES ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2013, FROM A CONSUMER AND CONCERNS A (B)(6) FEMALE PATIENT. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED PREMARIN AND ADDERALL. ON (B)(6) 2013, THE PATIENT WAS INJECTED WITH RESTYLANE ON THE FOREHEAD, LIP, AND UNDER THE EYES AND PERLANE ON THE MARIONETTE LINES. ON (B)(6) 2013, PATIENT STATED THAT SHE HAD FELT ILL THE DAY AFTER SHE RECEIVED THE INJECTIONS. ON (B)(6) 2013, THE PATIENT DEVELOPED SWELLING AT THE INJECTION SITES. THE PATIENT THEN VISITED HER PHYSICIAN ON (B)(6) 2013, AND WAS ADVISED TO TAKE BENADRYL AND WAS PRESCRIBED A STEROID CREAM WHICH PROVIDED NO IMPROVEMENT. ON (B)(6) 2013, THE PATIENT REPORTED FEELING ILL AGAIN. DESPITE USE OF THE STEROIDS AND BENADRYL, THE SWELLING HAD WORSENED TO THE POINT THAT HER EYES HAD SWOLLEN SHUT. SHE VISITED THE EMERGENCY ROOM (DATE UNKNOWN) AND WAS ADMINISTERED MORE STEROID WHICH PROVIDED LITTLE RELIEF. ON (B)(6) 2013, THE PATIENT SOUGHT THE HELP OF ANOTHER DERMATOLOGIST. THE DERMATOLOGIST DID NOT BELIEVE THAT THE SWELLING WAS AN INFECTION. HE HAD CUT THE AREAS OF SWELLING OPEN AND DETERMINED THAT THE PATIENT HAD DEVELOPED AN ALLERGIC RESPONSE TO THE RESTYLANE AND PERLANE. ON (B)(6) 2013, THE PATIENT WAS INJECTED WITH CORTISONE AT THE SITE OF SWELLING AND WAS ALSO PRESCRIBED MINOCYCLINE 100MG FOR 1 MONTH. PATIENT REPORTED LITTLE IMPROVEMENT DURING TIME OF CALL. PATIENT WAS ADVISED TO CONTACT HER PHYSICIAN FOR FURTHER CONSULTATION. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. CORRESPONDING ADVERSE EVENT REPORT FOR PERLANE WAS FILED UNDER (B)(4). NO INFORMATION ABOUT MEDICAL EVALUATION OR CAUSALITY ASSESSMENT WAS PROVIDED. THIS CASE IS LINKED TO CASE NUMBER-(B)(4). FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4) (MEDCOMM SOLUTIONS ON BEHALF OF (B)(4)). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305902 RESTYLANE, RESTYLANE /00567501/ INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other