Description of Event or Problem · 0
MAY BE EXPERIENCING A VASCULAR EVENT [VASCULAR OCCLUSION] REDNESS STARTED YESTERDAY AND THE AREA APPEARS DARKER NOW [SKIN DISCOLOURATION] REDNESS STARTED YESTERDAY AND THE AREA APPEARS DARKER NOW [ERYTHEMA] BLISTERS AND WHITEHEADS IN THE EFFECTED AREA [BLISTER] BLISTERS AND WHITEHEADS IN THE EFFECTED AREA [ACNE] RHA REDENSITY IN FOREHEAD [OFF LABEL USE] CASE NARRATIVE: UNITED STATES REPORT RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA COMPANY REPRESENTATIVE ON 01-JUL-2024, AND REFERS TO A FEMALE PATIENT OF UNKNOWN AGE WHO HAS RECEIVED RHA REDENSITY ON (B)(6) 2024 (FRIDAY), FOR UNKNOWN INDICATION. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS, AND FOOD SUPPLEMENTS WERE NOT PROVIDED. AN UNKNOWN VOLUME OF RHA REDENSITY WAS APPLIED, VERY SUPERFICIALLY, ON FOREHEAD VIA NEEDLE TECHNIQUE. IT WAS NOT REPORTED IF CANNULA WAS USED FOR THE ADMINISTRATION. NO ABNORMALITIES WERE NOTED. ON (B)(6) 2024 (REPORTED AS YESTERDAY), THE PATIENT EXPERIENCED BLISTERS, WHITEHEADS IN THE AFFECTED AREA AND REDNESS. AT THE TIME OF REPORT, THE AREA APPEARED DARKER. THE PATIENT WAS SUSPECTED TO HAVE EXPERIENCED A VASCULAR EVENT.THE HCP WAS PLANNING TO TO TREAT THE PATIENT WITH HYLENEX (HYALURONIDASE HUMAN INJECTION). AT THE TIME OF THIS REPORT, OUTCOME OF THE EVENTS WAS UNKNOWN. THE INTENSITY OF THE EVENTS WAS NOT REPORTED. IT WAS NOT REPORTED IF PRODUCT WAS AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE: E2328, OBSTRUCTION/OCCLUSION HEALTH EFFECT: CLINICAL CODE: E1716, SKIN DISCOLORATION HEALTH EFFECT: CLINICAL CODE: E171601, ERYTHEMA HEALTH EFFECT: CLINICAL CODE: E1703, BLISTER HEALTH EFFECT: CLINICAL CODE: E1717, SKIN DISORDERS HEALTH EFFECT ¿ DEVICE CODE: A2304 OFF-LABEL USE PICTURES OF PATIENT WERE PROVIDED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. CASE COMMENT: A CAUSAL RELATIONSHIP BETWEEN THE RHA REDENSITY AND REPORTED SUSPECTED VASCULAR OCCLUSION IS ASSESSED AS POSSIBLE BASED ON THE SUGGESTIVE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE ETIOLOGIES THAT CAN BE IDENTIFIED BASED ON THE INFORMATION REPORTED. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE PRODUCT.