Description of Event or Problem · 1
DESCRIPTION OF EVENT OR PROBLEM: THIS SERIOUS SPONTANEOUS DEVICE REPORT WAS RECEIVED FROM A CONSUMER IN THE UNITED STATES. THE PATIENT, A (B)(6)-YEAR-OLD FEMALE EXPERIENCED WHEEZING (COPD FLARE), ALLERGIC REACTION, SWOLLEN FEET, NUMBNESS IN ARMS, HANDS, AND FEET, SORE THROAT, RAPID HEARTBEAT, AND STRAINING OF HEART AFTER SHE RECEIVED THREE EUFLEXXA (1% SODIUM HYALURONATE) INJECTIONS IN AN UNSPECIFIED KNEE FOR KNEED PROBLEMS. LOT NUMBER: UNSPECIFIED. EXPIRATION DATE: UNSPECIFIED. ON (B)(6) 2014, THE PATIENT BEGAN EUFLEXXA THERAPY ON AN UNSPECIFIED KNEE FOR KNEE PROBLEMS. ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED THE SECOND EUFLEXXA INJECTION. ON (B)(6) 2014, THE PATIENT RECEIVED THE FINAL EUFLEXXA INJECTION OF HER FIRST SERIES. THE PATIENT REPORTED THAT HER KNEE (UNSPECIFIED) FELT BETTER. ON (B)(6) 2014, THE PATIENT EXPERIENCED WHEEZING WHICH CONTINUED TO GET WORSE. ON (B)(6) 2014, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR TREATMENT AND WAS HOSPITALIZED THROUGH (B)(6) 2014. THE PATIENT WAS TREATED FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) FLARE (TREATMENT UNSPECIFIED) BUT WAS NOT DIAGNOSED WITH COPD. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED HOME BUT CONTINUED TO EXPERIENCE WHEEZING. ON (B)(6) 2014, THE PATIENT WAS RE-ADMITTED AND WAS TREATED WITH STEROIDS (UNSPECIFIED) AND BENADRYL (DIPHENHYDRAMINE) FOR AN ALLERGIC REACTION. THE PATIENT REPORTED THE HOSPITAL "DID EVERYTHING" TO TREAT HER. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2014, SHE EXPERIENCED SWOLLEN FEET WHICH WAS TREATED WITH LASIX (FUROSEMIDE) (DOSE UNSPECIFIED), BUT THE SWELLING CONTINUED. SINCE THE PATIENT'S HOSPITALIZATIONS (ONSET DATE UNSPECIFIED), THE PATIENT EXPERIENCED NUMBNESS IN HER ARMS, HANDS, AND FEET THAT COMES AND GOES, A SORE THROAT THAT COMES AND GOES. DURING HER HOSPITALIZATION, SHE EXPERIENCED A RAPID HEARTBEAT, WHICH INCREASED WITH MOVEMENT. THE PATIENT REPORTED THAT SHE FELT SHE HAD AN ALLERGIC REACTION TO SOMETHING IN THE EUFLEXXA INJECTIONS AND THAT IT WAS STRAINING HER HEART. THE PATIENT STATED THAT SHE WAS NOT ALLERGIC TO EGGS, CHICKEN, OR FEATHERS. THE PATIENT REPORTED THAT HER PHYSICIAN DID NOT THINK EUFLEXXA CAUSED ALL OF HER EVENTS. AT THE TIME OF REPORTING, THE PATIENT WAS BEING TREATED BY HER PRIMARY CARE PHYSICIAN (TREATMENT UNSPECIFIED). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS ONGOING. NO MEDICAL HISTORY WAS REPORTED. CONCOMITANT MEDICATIONS WERE REPORTED AND INCLUDED AN UNSPECIFIED STOMACH PILL (DOSE UNSPECIFIED).