Description of Event or Problem · 1
A PHYSICIAN REPORTED THIS CASE TO THE FDA. IN 2001, THE PHYSICIAN WAS CONTACTED BY THE MARKETER OF THE DEVICE AND REPORTED THAT A PT EXPERIENCED "WORSENING OF SYMPTOMS" WHILE USING AEROCHAMBER WITH MASK (MEDIUM) FOR REACTIVE AIRWAY DISEASE. THE PHYSICIAN STATED THE PT WAS SEEN IN 1999 BY A COLLEAGUE OF THE REPORTER, AND WAS DIAGNOSED WITH REACTIVE AIRWAY DISEASE. THE PT WAS GIVEN ALBUTEROL MDI AND AEROCHAMBER WITH MASK (MEDIUM) TO BE USED 1-2 PUFFS Q 4. 16 DAYS LATER, THE REPORTING PHYSICIAN SAW THE PT BECAUSE THE PT WAS STILL HAVING PROBLEMS - WORSENING OF SYMPTOMS. THE REPORTER EXAMINED THE AEROCHAMBER WITH MASK AND NOTED THAT THE AEROCHAMBER DEVICE WAS MISSING AN EXHALATION VALVE. THE FAMILY AND THE PT BOTH DENY REMOVING THE VALVE. THE OLD AEROCHAMBER WITH MASK WAS REPLACED WITH A NEW ONE WITH ALL PARTS INTACT; THE PT IS DOING BETTER. NO RELEVANT TESTS/DATA WAS REPORTED. NO OTHER CONCOMITTANT MEDICATIONS OR RELEVANT MEDICAL HISTORY WERE REPORTED. THE PT CONTINUES THERAPY USING THE AEROCHAMBER WITH MASK. NO FURTHER INFO WAS PROVIDED. OUTCOMES ATTRIBUTED TO EVENT: PT RESPONDING TO TREATMENT.