Description of Event or Problem · 1
THIS IS A SPONTANEOUS CASE FROM THE USA. A FEMALE PT IN HER 80S, BEGAN HYALGAN FOR OSTEOARTHRITIS. THE PT'S RELEVANT MEDICAL HISTORY INCLUDES ASTHMA, SEASONAL ALLERGIES, AND PEANUT ALLERGY. THE PT DOES NOT HAVE AN ALLERGY TO CHICKENS. THE PT'S CONCOMITANT MEDICATIONS AND RELEVANT TESTS/LABORATORY DATA ARE UNK. ON AN UNSPECIFIED DATE IN 2014, THE PT BEGAN RECEIVING HYALGAN (UNK DOSE AND FREQUENCY) FOR OSTEOARTHRITIS IN THE LEFT KNEE. SHE RECEIVED HER FIRST INJECTION OF HYALGAN. A FEW DAYS LATER, THE PT REPORTED SHORTNESS OF BREATH. THE PT EXPERIENCED WORSENING SHORTNESS OF BREATH FOLLOWING HER SECOND AND THIRD INJECTIONS, BUT DID NOT REQUIRE ANY INTERVENTION. ON (B)(6) 2014, THE PT RECEIVED HER FOURTH INJECTION OF HYALGAN AND EXPERIENCED SHORTNESS OF BREATH REQUIRING A TRIP TO THE EMERGENCY DEPARTMENT. THE DOCTOR REPORTED THAT SHE EXPERIENCED AN ASTHMA ATTACK. SHE WAS TREATED WITH STEROIDS AND SHE WAS REFERRED TO AN ALLERGIST. ON AN UNK DATE, THE PT'S SYMPTOMS RESOLVED TO THE POINT WHERE SHE WAS ABLE TO TRAVEL. THE LOT NUMBER OF ALL 4 HYALGAN INJECTIONS IS 143500 AND THE EXPIRATION DATE IS 03/2016. AS OF (B)(6) 2014, THE PT WILL NO LONGER RECEIVE HYALGAN AND HER SYMPTOMS HAVE RESOLVED. MFR REF NUMBER: 9610200-2014-00012.