Description of Event or Problem · 1
THIS SPONTANEOUS REPORT WAS RECEIVED ON 11 MARCH 2019 FROM THE OWNER OF A MEDICAL SPA. ADDITIONAL DETAILS WERE ALSO RECEIVED ON 13 MARCH 2019 FROM THE NURSE INJECTOR AT MEDICAL SPA, WHO REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT USED LUMIERE EYE CREAM, LOT NUMBER UNKNOWN, AND EXPIRY DATE UNKNOWN. RELEVANT MEDICAL HISTORY INCLUDED THE PATIENT HAD BEEN SCRATCHED ON HER LEFT CHEEK BY HER DOG. THE SCRATCH REPORTEDLY HAD BECOME INFECTED AND WAS TREATED WITH ORAL ANTIBIOTICS. THE SYMPTOMS OF THE SCRATCH WERE RESOLVED PRIOR TO THE CONCOMITANT FACIAL INJECTION WITH ONE SYRINGE OF BELOTERO TO THE TEAR TROUGHS, ON (B)(6) 2019. (BELOTERO LOT NUMBER WAS REPORTED AS 321306). MEDICAL HISTORY WAS ALSO POSITIVE FOR HASHIMOTO'S THYROIDITIS AND PENICILLIN ALLERGY. CONCOMITANT MEDICATIONS ALSO INCLUDED SYNTHROID (LEVOTHYROXINE) AND PROGESTERONE. ON (B)(6) 2019, THE PATIENT BEGAN APPLYING LUMIERE EYE CREAM, UNDER THE EYES. ON (B)(6) 2019, THE PATIENT NOTICED ERYTHEMA (ERYTHEMA FACIAL) AND SWELLING OF THE LEFT CHEEK, WHICH SPREAD TO THE RIGHT CHEEK AND INCREASED IN VOLUME (FACIAL SWELLING). THE PATIENT STOPPED THE EYE CREAM ONCE HER SYMPTOMS BEGAN (SPECIFIC DATE UNKNOWN). THE PATIENT PRESENTED TO URGENT CARE AND WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC WITHOUT RESOLUTION. SHE WAS PRESCRIBED A SECOND A SECOND ANTIBIOTIC, DESCRIBED AS "MORE AGGRESSIVE", WITHOUT RESOLUTION. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SAW THE INFECTIOUS DISEASE (ID) PHYSICIAN AND WAS GIVEN TREATMENT WITH INTRAVENOUS ANTIBIOTICS. THE EVENTS REPORTED WERE SERIOUS, RESULTING IN THE PATIENT BEING HOSPITALIZED. THE PATIENT WAS ADMINISTERED AN UNSPECIFIED ANTIBIOTIC INTRAVENOUSLY WHICH REPORTEDLY DID NOT HELP. HER WHITE BLOOD CELL COUNT WAS NORMAL. ACCORDING TO THE ID PHYSICIAN, THE PATIENT HAD AN ALLERGIC REACTION TO "SOMETHING," RATHER THAN AN INFECTION (ALLERGIC SKIN REACTION). FURTHER CLARIFICATION FORM THE NURSE INCLUDED THAT TREATMENT FOR ALLERGIC REACTION WAS REPORTED AS STEROIDS WHILE IN THE HOSPITAL AND A MEDROL DOSEPACK (METHYLPREDNISOLONE) ON DISCHARGE. THE HOSPITAL PHYSICIAN REPORTED THE OUTCOME AS RESOLVED, HOWEVER, PER THE NURSE REPORTER, THE PATIENT PRESENTED FOR FOLLOW UP WITH THE INJECTOR ON (B)(6) 2019, AND HER SYMPTOMS WERE FURTHER CLARIFIED TO BE RESOLVING. IT WAS REPORTED THAT THE HOSPITAL PHYSICIAN FELT THE SYMPTOMS WERE RELATED TO BELOTERO, HOWEVER, PER THE NURSE INJECTOR, THE CAUSALITY WAS MOST LIKELY RELATED TO THE EYE CREAM. THE NURSE CLARIFIED THAT THE PHYSICIAN MAY NOT HAVE KNOWN ABOUT THE EYE CRAM, WHICH MAY BE WHY HE THOUGHT THE SYMPTOMS WERE RELATED TO THE BELOTERO FILLER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER ON (B)(6) 2019: THE PATIENT'S DATE OF BIRTH AND RACE (WHITE) WERE PROVIDED. THE PATIENT USED LUMIERE TOPICALLY, APPLYING A RICE GRAIN SIZE AMOUNT OF CREAM PER EYE TWICE DAILY, BEGINNING (B)(6) 2019 AND STOPPING ON (B)(6) 2019. AFTER STOPPING THE LUMIERE, THE PATIENT'S SYMPTOMS RESOLVED COMPLETELY BY (B)(6) 2019. THE PATIENT DID NOT RE CHALLENGE THE PRODUCT. IN THE OPINION OF THE REPORTER, THE EVENTS WERE POSSIBLY RELATED LUMIERE. ADVERSE EVENT TERMS: ERYTHEMA AND SWELLING OF LEFT CHEEK THAT SPREAD TO RIGHT CHEEK AND INCREASED IN VOLUME (ERYTHEMA ((B)(4))); ERYTHEMA AND SWELLING OF LEFT CHEEK THAT SPREAD TO RIGHT CHEEK AND INCREASED IN VOLUME (SWELLING FACE ((B)(4))); ALLERGIC REACTION TO LUMIERE EYE CREAM AND/ OR BELOTERO (DERMATITIS ALLERGIC (B)(4)).