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Event Date 04/06/2010
Event Type  Injury  
Event Description

(b) (6). I have interviewed, conducted a history review, and examined mr. (b) (6). It is apparent that he has developed sensitivity to aerosolized drug dust that is created by the pill-dispensing robot at the (b) (6) pharmacy. His sensitivity is severe, and re-exposure to the same environment will cause recurrence of his symptoms, which could progress very quickly and could result in death. Allergic sensitization to dust from medication is a well-known occupation hazard often seen in previous yrs in medication production and now with automated medication dispensing. Mr. (b) (6) symptoms are consistent with allergic sensitization to drug dust, one of which is amoxicillin. My recommendations are: he must not be assigned to the (b) (6) health building for any work. He must be given adequate space in another building. When these conditions are met, he may return to work without restrictions.

Event Description

The united states food and drug administration and congress have adopted "mandatory reporting" of medical devices suspected of, or what have actually caused health and safety issues, including death; life-threatening event; hospitalization; disability; health anomaly; or health impairment and damage. Background: (b) (6), lead pharmacist for the (b) (6), brought to our attention that she and other pharmacy staff were experiencing adverse health effects after installation of a parata robotic dispensing machine. She first reported problems in the latter part of 2006. She reported significant problems in the summer of 2007. In (b) (6) of 2007, she sought the assistance from mr (b) (6) to help address the issue. Repeated exposure to the (b) (6) pharmacy environment and "pill dust" while seeking to address the problem is suspected to have lead to mr (b) (6) sensitization, adverse reactions, unconsciousness, collapse, and emergency hospitalization. Mr (b) (6) has avoided exposure to the (b) (6) pharmacy since that time. Pill dust is again suspected of spreading around the entire building and caused repeated adverse health reactions for mr (b) (6). On (b) (6) 2010, a physician stated that mr (b) (6) is experiencing severe immune system reactions. The physician stated further that mr (b) (6) must completely avoid entering the building where the parata robotic dispensing machine is in operation. Since 2006, some staff that had adverse reactions relocated to other buildings and ms (b) (6) relocated out of state. Mr (b) (6) is the current lead pharmacist for the (b) (6) health center. The parata robotic dispensing machine is still in operation. The problematic issue with parata robots caught the attention of (b) (4). (b) (4) completed independent tests and confirms the potential adverse health problems associated with the parata robot. Two independent "peer reviews" of the studies also confirm the serious nature of the health hazard for pharmacy workers. (b) (4) and "technically qualified peers" call for federal review and action to address the problematic parata robotic dispensing machine and the dangers posed to people working in proximity to the robot (see attached study excerpts and peer review reports). This protracted problem is potentially fatal for people who have become sensitized and breath in the microscopic "pill dust" generated by the parata robotic dispensing machine. The issue should be addressed in a professional manner that respects public health, safety, and welfare. Examining physician advise: "don't go in that building. " continued exposure could lead to a potentially fatal immune system response. Full chemical gear with an oxygen tank would be required.

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MDR Report Key1657874
Report NumberMW5015511
Device Sequence Number1
Product CodeNEP
Report Source Voluntary
Type of Report Initial,Followup,Followup
Report Date 04/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER

Date Received: 05/20/2010 Patient Sequence Number: 1