BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 4593689 · Received March 11, 2015

    Report

    Report Number
    9710154-2015-00006
    Event Type
    Injury
    Date Received
    March 11, 2015
    Report Date
    February 23, 2015
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: GALDERMA LABORATORIES L.P. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF Q-MEDS AB (MANUFACTURER) . EXEMPTION NUMBER: (B)(4). PHARMACOVIGILANCE COMMENT: A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT SEEMS POSSIBLE. THE INJECTION TECHNIQUE OR THE INJECTION PROCEDURE PER SE MAY ALSO HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    (B)(4) IS A LITERATURE REPORT SENT ON (B)(6)-2015 BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED (B)(6). (WS LEE ET AL. MULTIPLE CEREBRAL INFARCTIONS WITH NEUROLOGICAL SYMPTOMS AND OPHTHALMIC ARTERY OCCLUSION AFTER FILLER INJECTION. J KOREAN OPHTHALMOL SOC. 2015; 56(2): 285-290). A (B)(6) FEMALE VISITED OUR CLINIC FOR VISUAL LOSS IN THE LEFT EYE AFTER FILLER INJECTION (RESTYLANE) IN THE GLABELLA. HER BEST CORRECTED VISUAL ACUITY WAS 1.0 IN THE RIGHT EYE AND HAND MOTION IN THE LEFT EYE. THE INTRAOCULAR PRESSURE WAS 8 MM HG IN THE RIGHT EYE AND 14 MM HG IN THE LEFT EYE. IN THE LEFT EYE, THERE WAS ABNORMAL PUPILLARY LIGHT REFLEX AND COMPLETE EXTRA-OCULAR MUSCLES PALSY WITH BLEPHAROPTOSIS. A PALE RETINA WITH A CHERRY-RED-SPOT ALSO APPEARED IN THE LEFT FUNDUS. A CENTRAL RETINAL ARTERY OCCLUSION WAS OBSERVED ON FLUORESCEIN ANGIOGRAPHY ND BRAIN MAGNETIC RESONANCE IMAGING SHOWED MULTIPLE CEREBRAL INFARCTIONS AT THE FRONTAL, TEMPORAL, PARIETAL AND OCCIPITAL LOBES. SHE HAD DIZZINESS, CHANGE AND LEVEL OF THE CONSCIOUSNESS, DYSARTHRIA, AND APHASIA AS, GENERAL SYMPTOMS. MOREOVER, SHE HAD A MOTOR WEAKNESS OF HER RIGHT PARTS (ARM AND LEG). SHE WAS ADMITTED TO THE UNIVERSITY HOSPITAL. SHE TOOK ORAL MEDICATION (ASPIRIN), AND IV THERAPY (UNKNOWN FLUID). FOUR DAYS LATER, THE MOTOR WEAKNESS WAS AGGRAVATED AND DYSARTHRIA AND APHASIA BECAME WORSE. ACCORDING TO SYMPTOMS, A HEMORRHAGIC TRANSFORMATION IN SUBACUTE INFARCTIONS DEVELOPED BASED ON BRAIN COMPUTED TOMOGRAPHY. FOR 3 MONTHS, SHE RECEIVED LANGUAGE REHABILITATION AND EXERCISE REHABILITATION. AFTER 3 MONTHS OF FOLLOW UP, THE VISUAL ACUITY IN THE LEFT EYE WAS NO LIGHT PERCEPTION. HOWEVER, THE GENERAL CONDITIONS INCLUDING OPHTHALMOPLEGIA AND MOTOR WEAKNESS WERE IMPROVED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED: CENTRAL RETINAL ARTERY OCCLUSION (RETINAL ARTERY OCCLUSION); VISUAL LOSS (BLINDNESS); CORNEAL EDEMA (CORNEAL OEDEMA); BLEPHAROPTOSIS (EYELID PTOSIS); BRUISE (CONTUSION) AT NOSE; OPTHALMIC ARTERY OCCLUSION (CAROTID ARTERY OCCLUSION); MULTIPLE CEREBRAL INFARCTION (FRONTAL, TEMPORAL, PARIETAL AND OCCIPITAL LOBES) (CEREBRAL INFARCTION); CHANGE OF THE LEVEL OF CONSCIOUSNESS (ALTERED STATE OF CONSCIOUSNESS); DYSARTHRIA (DYSARTHRIA); APHASIA (APHASIA); HEMORRHAGIC TRANSFORMATION IN THE SUBACUTE INFARCTION (HAEMORRHAGIC TRANSFORMATION STROKE); DIZZINESS (DIZZINESS); MOTOR WEAKNESS IN RIGHT EXTREMITIES (HEMIPARESIS); OPHTHALMOPHLEGIA (OPHTHALMOPLEGIA); SUBCONJUNCTIVAL HEMORRHAGE (CONJUNCTIVAL HAEMORRHAGE); SUBCONJUNCTIVAL SWELLING (CONJUNCTIVAL OEDEMA). THE COMPANY HAS ASSESSED ALL THE REPORTED EVENTS AS POSSIBLE RELATED TO THE TREATMENT WITH RESTYLANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168048 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE (LMH) LMH GALDERMA Q-MED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S