BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1172713 · Received September 12, 2008

    Report

    Report Number
    9710154-2008-00014
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA # P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF NON-SERIOUS, UNLABELED EVENTS (ANGIOEDEMA, LYMPHADENOPATHY, DYSPNEA, STOMATITIS, EDEMA PERIPHERAL AND LARYNGEAL EDEMA) MEETS THE CRITERIA OF AN EXPEDITED 10-DAY REPORT. INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (DIRECTOR OF THE INJECTING FACILITY) REGARDING A (B) (6) FEMALE WHO RECEIVED INJECTIONS OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO THE "MOLAR REGION AND LIPS" ON (B) (6) 2008 AND (B) (6) 2008. NO ANESTHESIA WAS REPORTED USED PRIOR TO PROCEDURE. NO ADDITIONAL PROCEDURE WAS PERFORMED. SIGNIFICANT PAST MEDICAL HISTORY INCLUDED ENDOMETRIOSIS AND PREVIOUS RESTYLANE INJECTIONS INTO THE MOLAR REGION AND LIPS AT MULTIPLE TIMES A YEAR BY THE SAME PHYSICIAN FOR THE PAST COUPLE OF YEARS. IN (B) (6) 2006, RESTYLANE INJECTION WAS PERFORMED INTO UNSPECIFIED AREAS AND IN (B) (6) 2007, SHE HAD JUVEDERM INJECTION. CONCURRENT MEDICATIONS INCLUDED BENADRYL (DIPHENHYDRAMINE CHLORIDE) 25 MG FOUR TO FIVE TIMES A DAY AND RANITIDINE (BRAND NAME, FORM, ROUTE AND FREQUENCY UNSPECIFIED). ON OR ABOUT THE END OF (B) (6) 2008 AND BEGINNING WEEK OF (B) (6) 2008, THE PATIENT DEVELOPED SWELLING OF HER LOWER LIP THAT LASTED THREE DAYS (IMPLANT SITE SWELLING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB 9259

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other FOUR TO FIVE TIMES A DAY| BENADRYL (DIPENHYDRAMINE CHLORIDE) 25 MG,| RANITIDINE (BRAND NAME UNSPECIFIED)