It was reported that a patient is having an adverse reaction after having ar-2290 (lot: 1022169) and a cadaver bone graft implanted during a procedure that took place on (b)(6) 2018.The patient noticed a rash around the surgical site on (b)(6) 2018, ten days after the procedure.The patient's rash around the surgical site was very red, itchy, raised, swollen and hot to the touch.The patient had a follow up visit with their surgeon, and had a visit with their primary physician.The primary physician told the patient that they are experiencing an adverse reaction, and to continue to monitor the symptoms.Allergen testing has not been done as of (b)(6) 2018, and the patient has another follow-up visit scheduled with their surgeon on (b)(6) 2019.The patient has been treating the symptoms with benadryl.The patient stated that they are allergic to certain metals.Additional information has been requested.
|