BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1032491 · Received April 17, 2008

    Report

    Report Number
    9710154-2008-00005
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 9, 2008
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    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 FACIAL) IS BEING SUBMITTED AS A 10-DAY REPORT. A (B) (6) FEMALE PT REPORTED RECEIVING AN INJECTION OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO THE NASOLABIAL FOLDS ON (B) (6) 2008. ANESTHESIA IN THE FORM OF LIDOCAINE WAS USED PRE-PROCEDURE. MEDICAL HISTORY INCLUDED PRIOR USE OF RESTYLANE WITHOUT DIFFICULTY AND NO KNOWN ALLERGIES. CONCOMITANT MEDICATIONS INCLUDED ASPIRIN 325 MG BY MOUTH DAILY (THE PT REPORTED NOT TAKING ASPIRIN ON THE DAY OF TREATMENT). ON THE EVENING OF (B) (6) 2008, THE PT DEVELOPED FEELING NUMB ON THE RIGHT SIDE OF HER FACE AND NOSE (HYPOAESTHESIA FACIAL), AND PATCHY REDNESS (ERYTHEMA). THE PT REPORTED THE REDNESS EXTENDS BEYOND THE TREATMENT SITE TO ACROSS HER EYEBROW AREA. THE EVENTS WERE ONGOING AS OF THE DATE THIS REPORT WAS REC'D. THE RESTYLANE 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 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR ASPIRIN 325 MG BY MOUTH DAILY