Description of Event or Problem · 0
I LIVE AND WORK OVER IN (B)(6), HOWEVER, MY HOSPITAL NETWORK USES A DEVICE FROM A US DEVICE MANUFACTURER. THE DEVICE IS THE MICROSTAR DEVICE, MANUFACTURED BY LANDAUER. LANDAUER IS BASED OUT OF (B)(4). I WANTED TO PLACE A FORMAL COMPLAINT USING MY PERSONAL EMAIL ANONYMOUSLY DUE TO MULTIPLE ISSUES WE HAVE BEEN HAVING WITH THIS DEVICE IN OUR COUNTRY AND ACROSS (B)(6). THE DEVICE IS INTENDED TO LET PRACTITIONERS KNOW THE AMOUNT OF RADIATION EXPOSURE A PATIENT HAS BEEN EXPOSED FROM TREATMENT. THESE DEVICES HAVE BEEN UNDERREPORTING THE AMOUNT OF RADIATION EXPOSURE TO THE PATIENT, RESULTING IN UNKNOWN RISKS AND HAZARDS TO OUR PATIENTS. LANDAUER HAS NOT ISSUED ANY SORT OF RECALL OR PROVIDED ANY KIND OF CORRESPONDENCE ABOUT FIXING OR EVEN ACKNOWLEDGING THE ISSUE WITH THE MICROSTAR AND NANO DOT DEVICES. WE HAVE SEVERAL FACILITIES ACROSS MULTIPLE COUNTRIES IN (B)(6) AND WE KNOW THERE ARE LEGAL ISSUES FROM THIS DEVICE NOT BEING APPROPRIATELY CLASSIFIED IN EUROPE AS A DEVICE IN SEVERAL COUNTRIES. WE CANNOT EVEN DETERMINE THE EXTENT OF THE AMOUNT OF RADIATION EXPOSURE TO OUR PATIENTS BECAUSE OF THE NATURE OF DEVICE. I STRONGLY URGE YOU AND YOUR OFFICE TO INVESTIGATE THIS DEVICE AND EVALUATE WHETHER IT¿S SAFE FOR USE. I AM NOT SURE ABOUT ANY ISSUES IN THE US, HOWEVER, THERE ARE MANY OVER HERE IN EUROPE. WE DON¿T FEEL THIS DEVICE IS SAFE FOR USE AND WANT THE MANUFACTURER HELD ACCOUNTABLE FOR THEIR LACK OF ACTION WITH THIS DEFECTIVE DEVICE. LASTLY, I HOPE YOU DON¿T MIND THAT I CONTACTED YOU DIRECTLY. I GOT YOUR INFORMATION FROM A CONTACT AT THE COMMISSION OVER HERE IN EUROPE. I AM NOT SURE OF THE PROCESS FOR REPORTING QUALITY ISSUES IN THE FDA. AS A RESULT, YOU WERE THE BEST OPTION I FEEL TO BRING AWARENESS AND HOPEFULLY TAKE ACTION ON THIS ISSUE.