BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1074005 · Received July 9, 2008

    Report

    Report Number
    9710154-2008-00010
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K) P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT (HYPOAESTHESIA) IS BEING SUBMITTED AS A 10 DAY REPORT. A HEALTH CARE PROVIDER REPORTED THAT A (B) (6) FEMALE PATIENT RECEIVED INJECTIONS OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO THE VERMILLION BORDER, LOWER LIP AND NASOLABIAL FOLD ON AN UNSPECIFIED DATE IN (B) (6) 2008. ANESTHESIA PRE PROCEDURE INCLUDED AN INFRAORBITAL BLOCK OF 1CC LIDOCAINE WITH EPINEPHRINE WAS INJECTED INTO 4 SITES, 2 INFRAORBITAL AND 2 MENTAL FORAMEN SITES. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ONE WEEK POST INJECTION, THE PATIENT COMPLAINED OF NUMBNESS (HYPOAESTHESIA) APPROXIMATELY A "QUARTER SIZE" BELOW THE LIP AND IN THE CHEEK. THE PHYSICIAN PRESCRIBED PREDNISONE. THE PHYSICIAN STATED THE NUMBNESS IS NOT AT THE INJECTIONS SITES OF EITHER THE RESTYLANE OR THE ANESTHETIC BUT IN THE AREA. THE PATIENT WAS REFERRED TO A NEUROLOGIST. AS OF (B) (6) 2008, THE EVENT WAS ONGOING. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR