BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 5230760 · Received November 17, 2015

    Report

    Report Number
    9710154-2015-00078
    Event Type
    Injury
    Date Received
    November 17, 2015
    Report Date
    November 17, 2015
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENTS: A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT WITH UNSPECIFIED HYALURONIC ACID SEEM POSSIBLE. AS SIMILAR ADVERSE EVENTS ALSO CAN OCCUR AFTER INJECTION WITH OTHER SUBSTANCES IN THE SAME AREA, THE ADVERSE EVENTS ARE ASSESSED AS RELATED TO THE INJECTION PROCEDURE AND NOT SPECIFICALLY THE PRODUCT. DUE TO ITS SEVERITY THE CASE REPORT IS ASSESSED AS A SERIOUS ADVERSE EVENT. A CASE OF A PRESUMABLE OBSTRUCTIVE SYMPTOM IN THE OPHTHALMIC ARTERY BRANCH WHICH DEVELOPED AFTER HYALURONIC ACID INFUSION TO THE NASAL ROOT PROGRAM/ABSTRACTS FOR THE (B)(6). THE EVENTS OCULAR VASCULAR DISORDER, EYE MOVEMENT DISORDER, STRABISMUS, EYE PAIN, PAPILLOEDEMA, FEELING ABNORMAL AND VISUAL ACUITY REDUCED ARE NOT EXPLICITLY MENTIONED IN THE LABELING, BUT IS ASSESSED TO BE SYMPTOMS OF THE LABELLED EVENT VISUAL DISTURBANCE, ISCHEMIA AND VASCULAR COMPROMISE. THE OCCURRENCE OF THE EVENT WILL BE CONTINUOUSLY MONITORED WITHIN THE NORMAL DEVICE VIGILANCE PROCESS. NO FURTHER CORRECTIVE ACTION INITIATED. TREATMENT WITH UNSPECIFIED PRODUCT, NO LOT NO WAS PROVIDED.

    Description of Event or Problem · 1

    THIS LITERATURE CASE, (B)(4), RECEIVED ON 10-NOV-2015 DESCRIBES THE FOLLOWING CASE: A (B)(6) WOMAN RECEIVED HYALURONIC ACID (UNKNOWN BRAND) INFUSION TO THE NASAL ROOT IN A COSMETIC SURGERY CLINIC. AFTER THE TREATMENT THE PATIENT COMPLAINED OF POOR FEELING, LEFT EYE PAIN, AND REDUCED VISUAL ACUITY IN THE LEFT EYE, AND WAS TRANSFERRED TO THE DEPARTMENT OF CRITICAL CARE AND EMERGENCY IN THE AUTHORS' HOSPITAL. WHEN THE PATIENT HAD CONSULTATION IT WAS DIFFICULT TO PERFORM VISUAL ACUITY TESTS ADEQUATELY DUE TO POOR FEELING. HOWEVER, THE PATIENT HAD NORMAL LIGHT REFLEX, CRITICAL FLICKER/FUSION FREQUENCY (CFF) WITHIN THE NORMAL RANGE WITH NO LATERALITY, AND NORMAL OCULAR FUNDUS ON OPHTHALMOSCOPY, BUT MILD ADDUCTION DISORDER IN THE LEFT EYE. IN THE CLINICAL COURSE, PAPILLOEDEMA DEVELOPED IN THE LEFT EYE. GOLDMANN PERIMETRY SHOWED VISUAL FIELD DEFECT ON THE NOSE SIDE OF THE LEFT EYE. FLUORESCEIN FUNDUS ANGIOGRAPHY SHOWED DELAYED APPEARANCE OF BACKGROUND FLUORESCENCE IN THE SITE OF THE OCULAR FUNDUS CORRESPONDING TO VISUAL FIELD DEFECT. ADDUCTION DISORDER IN THE LEFT EYE DETERIORATED AND LED TO HYPER-EXOTROPIA. ORBITAL MAGNETIC RESONANCE IMAGING (MRI) SHOWED HIGH SIGNAL INTENSITY IN THE SUPERIOR OBLIQUE MUSCLE, THE MEDIAL RECTUS MUSCLE, THE INFERIOR OBLIQUE MUSCLE, AND THE INFERIOR RECTUS MUSCLE IN BOTH EYES. CONSIDERING EYE MOVEMENT DISORDER, ISCHAEMIA IN THE FEEDING VESSELS OF THE EXTERNAL OCULAR MUSCLES WAS SUSPECTED. AS THE PATIENT WAS CONSIDERED TO HAVE AN OBSTRUCTIVE SYMPTOM IN THE OPHTHALMIC ARTERY BRANCH, ADMINISTRATION OF PROSTAGLANDIN PREPARATION AND ASPIRIN WAS CONTINUED, STEROIDS WERE ADMINISTERED TO IMPROVE THE PAPILLOEDEMA AND INSTILLATION OF DORZOLAMIDE/TIMOLOL WAS PERFORMED TO IMPROVE OPTIC DISC CIRCULATION. ALTHOUGH VISUAL FIELD DEFECT REMAINED AT THE MOMENT, VISUAL ACUITY WAS FAVOURABLE, AND EYE MOVEMENT AND EYE POSITION WERE ALMOST NORMALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761778 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other