BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 7530157 · Received May 21, 2018

    Report

    Report Number
    9710154-2018-00036
    Event Type
    Injury
    Date Received
    May 21, 2018
    Report Date
    May 21, 2018
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. ENGINEERING EVALUATION: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENTS OF PSEUDOCYST AND VASCULAR COMPRESSION WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS INCLUDING HYALURONIDASE, NITROGLYCERIN, LOW DOSE ASPIRIN, TOPICAL ANTIBIOTICS, HYPERBARIC OXYGEN THERAPY, LIGHT EMITTING DIODE IRRADIATION AND SUPPORTIVE SKIN CARE. THE NON-SERIOUS EXPECTED EVENTS OF IMPLANT SITE PAIN, IMPLANT SITE DISCOLOURATION, IMPLANT SITE PALLOR, IMPLANT SITE ERYTHEMA AND THE UNEXPECTED EVENTS OF LIVIDITY AND PURPURA WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. POTENTIAL CONTRIBUTORY FACTORS INCLUDE INJECTION TECHNIQUE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EXEMPTION: EXEMPTION NUMBER: E2015005 GALDERMA LABORATORIES, L.P. (IMPORTER REGISTRATION NUMBER: 1000118068) IS SUBMITTING THE REPORT ON BEHALF OF Q-MED AB (MANUFACTURER REGISTRATION NUMBER: 9710154). - ATTACHMENT: [9710154-2018-00036 ARTICLE.PDF]

    Description of Event or Problem · 0

    THIS CASE IS A LITERATURE REPORT WITH (B)(4) AND WAS RECEIVED ON 22-MAY-2017 BY E-MAIL. G.R AHN ET AL. THE UTILITY OF COLOR DOPPLER ULTRASOUND TO EXPLORE VASCULAR COMPLICATIONS FOLLOWING FILLER INJECTION. THE KOREAN DERMATOLOGICAL ASSOCIATION. 2017. P304. A (B)(6) FEMALE PRESENTED TO WITH DISCOLORATION, PAIN ON HER RIGHT CHEEK OCCURRED AFTER HYALURONIC ACID (HA) FILLER INJECTION ON RIGHT NASOLABIAL FOLD. A DOPPLER ULTRASOUND EXAMINATION SHOWED A HYPOECHOIC PSEUDOCYST COMPRESSING THE NEAR VESSEL. UNDER GUIDANCE WITH ULTRASOUND, HYALURONIDASE WAS IMMEDIATELY INJECTED INTO THE PSEUDOCYST. FOLLOWING ADDITIONAL TREATMENT INCLUDING SUBLINGUAL NITROGLYCERIN AND LOW-DOSE ASPIRIN ADMINISTRATION, SALINE SOAKING, TOPICAL ANTIBIOTICS, HYPERBARIC OXYGEN THERAPY, 833-NM LED IRRADIATION, AND OCCLUSIVE DRESSING, THE SKIN LESIONS WERE COMPLETELY RESOLVED WITHOUT ANY SCARRING OR DEFECT. G.R AHN ET AL. THE UTILITY OF COLOR DOPPLER ULTRASOUND TO EXPLORE VASCULAR COMPLICATIONS FOLLOWING FILLER INJECTION. DERMATOL SURG. 2017 DEC;43(12):1508-1510. A (B)(6) WOMAN PRESENTED DISCOLORATION AND PAIN ON HER RIGHT CHEEK ON THE SAME DAY AS UNDERGOING AUGMENTATION OF THE RIGHT NASOLABIAL FOLD WITH RESTYLANE (Q-MED, UPPSALA, SWEDEN) IN THE LOCAL CLINIC. RIGHT AFTER THE INJECTION, SHE SUFFERED FROM PAIN AND IMMEDIATE BLANCHING ON HER NASOLABIAL FOLD. OWING TO PERSISTENT PAIN AND SUBSEQUENT ERYTHEMA AROUND THE INJECTION SITE, SHE WAS REFERRED TO THE AUTHORS' HOSPITAL. ON PHYSICAL EXAMINATION, LIVEDOID PURPURIC PATCHES WERE NOTED ON HER RIGHT NASOLABIAL FOLD, NOSE, AND GLABELLA WITHOUT EVIDENCE OF SKIN NECROSIS. A DOPPLER ULTRASOUND EXAMINATION SHOWED A HYPOECHOIC PSEUDOCYST COMPOSED OF HYALURONIC ACID (HA) FILLER SITUATED DIRECTLY NEAR THE RIGHT ANGULAR ARTERY. THE DIMENSIONS OF THE VESSEL WERE 1.2 X 1.3 MM BECAUSE OF COMPRESSION BY THE HA FILLER. HYALURONIDASE 1,500 IU WAS IMMEDIATELY INJECTED INTO THIS PSEUDOCYST UNDER ULTRASOUND GUIDANCE. AFTER THE PROCEDURE, PAIN ON HER CHEEK WAS NEARLY RESOLVED BECAUSE OF DECLINING PRESSURE ON THE INJURED VESSELS, BUT THE PURPURIC PATCHES REMAINED ON HER CHEEKS. TO INCREASE BLOOD FLOW, SUBLINGUAL NITROGLYCERIN AND LOW DOSE ASPIRIN (100 MG/D) WERE PRESCRIBED FOR 1 WEEK. ALSO, SALINE SOAKING, TOPICAL ANTIBIOTICS, HYPERBARIC OXYGEN THERAPY, 833-NM LIGHT EMITTING DIODE IRRADIATION, AND OCCLUSIVE DRESSING OF VASELINE PETROLATUM GAUZE WERE PERFORMED DAILY DURING INITIAL 2 WEEKS OF ACUTE PHASE. AFTER 8 WEEKS, PHYSICAL EXAMINATION REVEALED NEGLIGIBLE PIGMENTATION WITHOUT ANY SCARRING OR DEFECT. CLINICAL RESOLUTION AT 8 WEEKS AFTER TREATMENT. WITH DOPPLER ULTRASOUND, 1.5 X 2.3 MM-SIZED DILATED VESSELS AND REMAINING HA WERE OBSERVED AT 8 WEEKS OF FOLLOW-UP. CLINICAL RESOLUTION AT 8 WEEKS AFTER TREATMENT. TRACKING LIST: V. 0, INITIAL V. 1, FULL ARTICLE RECEIVED ON 08-MAY-2018: THE CASE WAS UPDATED AND UPGRADED TO SERIOUS. ADDED EVENTS OF BLANCHING, ERYTHEMA AND LIVEDOID PURPURIC PATCHES. DETAILS OF CORRECTIVE TREATMENTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372097 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention