Description of Event or Problem · 1
ON (B)(6) 2012, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A (B)(4) YR OLD MALE WHO WAS BEING TREATED WITH PROTOPIC 0.1% OINTMENT (ASTELLAS) AND HYLATOPICPLUS 5 GM. ON (B)(6) 2012, ADD'L INFO WAS RECEIVED FROM THE CONSUMER AND THE CASE WAS ASSESSED AS SERIOUS, UNEXPECTED. MEDICAL HISTORY INCLUDED BROKEN NECK AND SEVERING OR LOSS OF AN ARM (FELL OUT OF A HELICOPTER IN 1996); NECK SURGERY (RESULTED IN PARALYZING OF HIS LUNGS, ONE OF WHICH RECOVERED); PANCREATIC CANCER; WHIPPLE SURGERY (IN OR AROUND 2009); MINERAL OIL ALLERGY FIRST NOTED WHEN HE WAS PRESCRIBED REGULAR (NON-AUGMENTED) TOPICAL BETAMETHASONE RESULTING IN EYE PRESSURE SOARING TO 40, GLAUCOMA, LOSS OF VISION IN HIS LEFT EYE AND LOSING VISION IN HIS RIGHT EYE; EGG ALLERGY (ALLERGIC REACTION ON HIS SKIN ON (B)(6) 2012 FROM EGGS IN A SANDWICH); AND ERYTHROMYCIN ALLERGY. CONCOMITANT MEDICATIONS INCLUDED LOVAZA (OMEGA 3 ACID ETHYL ESTERS), AZOPT (BRINZOLAMIDE) EYE DROPS, AND AN UNSPECIFIED "BLOOD PRESSURE PREVENTIVE." ON AN UNREPORTED DATE, THE PT DID A "TEST PATCH" WITH HYLATOPICPLUS 5 GM AND DID NOT HAVE A REACTION. ON (B)(6) 2012, THE PT APPLIED HYLATOPICPLUS 5 GM TO HIS EXTREMITIES (ARMS AND LEGS), CHEST AND ARMS FOLLOWING HIS ALLERGIC REACTION ON (B)(6) 2012. THE PT ALSO STARTED TREATMENT WITH PROTOPIC 0.1% OINTMENT (ASTELLAS). ON AN UNSPECIFIED DATE (EITHER (B)(6) 2012), THE PT DEVELOPED A SYSTEMIC ALLERGIC REACTION WITH SEVERE PAIN AND EDEMA OF HIS NECK AND FACE, HIS CHEST WAS VERY IRRITATED AND PUFFY, AND HE DEVELOPED LESIONS DESCRIBED AS CUTS IN THE SKIN THAT WERE BLEEDING. THE PT THOUGHT HIS EVENTS WERE SERIOUS ENOUGH TO WARRANT A TRIP TO THE EMERGENCY ROOM, BUT HE DID NOT GO AS HIS WIFE IS A NURSE AND HE HAD INCENSED HEALTHCARE PROVIDERS AT HIS HOME (NOT CLARIFIED FURTHER). ON (B)(6) 2012, FOLLOWING THE DEVELOPMENT OF EVENTS, THE PT WAS EVALUATED BY AN ALLERGIST, DERMATOLOGIST, EYE DOCTOR AND EYE SURGEON. HE HAD A F/U VISIT WITH ONE OF THE PHYSICIANS (UNSPECIFIED) ON (B)(6) 2012 AND A F/U VISIT WAS SCHEDULED WITH ANOTHER UNSPECIFIED PHYSICIAN ON (B)(6) 2012. SPECIFICS REGARDING THE APPOINTMENTS WERE NOT REPORTED, BUT THE PT WAS TREATED WITH MEDROL (METHYLPREDNISOLONE), PREDNISONE AND TOPICAL "AUGMENTED" BETAMETHASONE (WHICH DOESN'T CONTAIN MINERAL OIL). THE PT DID NOT BELIEVE THAT EVENTS WERE RELATED TO PRODUCT USE, BUT HE DISCONTINUED TREATMENT WITH HYLATOPICPLUS AFTER 3 DAYS OF USE (10/19/2012) BECAUSE HIS SAMPLE RAN OUT. HE HAD ORDERED MORE AND WAS PLANNING TO USE IT AGAIN IF IT COULD BE CLARIFIED THAT IT DOES IT CONTAIN MINERAL OIL. AS OF (B)(6) 2012, THE EVENTS WERE ONGOING. NO ADD'L INFO WAS PROVIDED.