Description of Event or Problem · 0
I CURRENTLY MANAGE A BUSINESS THAT MANUFACTURES AN ELECTRIC MEDICAL DEVICE (W/501K) CALLED SUDOSCAN THAT MEASURES FOR NEUROPATHY. I'M, AN ADMIN FOR THE FDA ON BEHALF OF THE COMPANY. FOR SOME TIME NOW I HAVE VOICED MY CONCERNS ABOUT THE INCREASING NUMBERS OF MALFUNCTIONING DEVICES WE'VE SOLD. WHILE THE TECHNOLOGY IS THE SAME, THE SYSTEM HAS EVOLVED OVER THE COURSE OF THE LAST FEW YEARS. COMPANY OWNERSHIP HAS ALSO CHANGED. THE NEW OWNERS, (B)(6), HAVE PLANNED TO IMPLEMENT SUDOSCAN TECHNOLOGY IN A PUBLICLY USED SCALE GLOBALLY. WE'VE RECENTLY RECEIVED A NOTICE FROM THE FDA THAT THERE WAS AN INCIDENT OR INJURY THAT INVOLVED A SUDOSCAN DEVICE. IN THE REPORT, THE NEGATIVE EFFECTS THE PATIENT WAS FEELING AFTER TESTING ON THE DEVICE WERE WRITTEN IN DETAIL. I COULDN' T IDENTIFY THE EXACT DEVICE USED WITH THE INFORMATION WE RECEIVED IN THE REPORT, BUT I NOTED THE EVENT, AND I GAVE ANY DETAILS. I DID HAVE TO LEADERSHIP AND OUR COMPLIANCE DEPT. WE SUBMITTED A RESPONSE AND DO NOT HAVE ANY INFORMATION ON THE OUTCOME. I WAS CLEAR IN MANY COMMUNICATIONS WITH MY SUPERVISOR THAT I HAD CONCERNS ABOUT THE QUALITY AND MALFUNCTIONING ABOUT OUR DEVICES, AND WE SHOULD "HEAVILY" CONSIDER IT WITH THE FDA COMPLAINT WE RECEIVED. NOT LONG AFTER THE COMPLAINT, MY EMPLOYEES TESTED A SIMILAR DEVICE WE HAD IN THE OFFICE THAT HAS THE SAME TECHNOLOGY USED AS OURS. MY STAFF WAS ASKED BY LEADERSHIP TO TEST THIS VIRTUALLY IDENTICAL PRODUCT TO SEND SAMPLE REPORTS TO OUR HEADQUARTERS IN FRANCE. THE AFTERNOON OF THURS, (B)(6) 2014. I GATHERED THE "TEAM" TO VIDEO RECORD MY TESTING OF THE DEVICE TO SEND TO THE LEADERSHIP TEAM. AFTER TAKING THE TEST, MY FEET AND HANDS FELT BURNED. I IMMEDIATELY MESSAGED MY SUPERVISOR IN FRANCE ABOUT THE INCIDENT. MY EMPLOYEE THEN NOTIFIED ME THAT HE FELT A NEGATIVE EFFECT AS WELL WHEN HE TRIED IT. THE OTHER EMPLOYEE, THAT NOW HAS U WORKER'S COMP CLAIM AS WELL, DID STATE IT MAY NOT BE AS BAD AS MINE AFTER I TOOK THE TEST. THE NEXT DAY MY FEET AND HANDS WERE ESPECIALLY BURNED AND MY DOCTOR ASKED TO COME IN. I WENT TO THE DR TO FIND I HAD NERVE DAMAGE IN MY HANDS AND FEET. THE DOCTOR STATED THAT IF I WAS TO BE DIABETIC, MY INJURIES COULD BE PERMANENT. I AM STILL GETTING EVALUATED AND DEALING WITH THE PAIN AND INJURIES FROM THE INCIDENT. THE DEVICE USED IS THE SAME EXACT TECHNOLOGY WE USE. WITHIN A WEEK OF THE REPORTED INJURY OF BOTH ME AND THE OTHER EMPLOYEE, HUMAN RESOURCES ARRANGED AN IMPROMPTU MEETING WITH ME. IN THE MEETING I WAS BEING PRESSURED TO COLLABORATE A REASON TO FIRE MY EMPLOYEE WITH AN UNWARRANTED ACCUSATIONS. WHEN I REFUSED, A "SMEAR" CAMPAIGN BEGUN. I'VE BEEN WITH THE COMPANY FOR ALMOST 4 YEARS. I AM A TOP PERFORMER AND AM KNOWN FOR MY HIGH EXPECTATION OF PROFESSIONALISM WITH MY TEAM. I HAVE NEVER HAD A PERFORMANCE NOR ANY OTHER ISSUE UNTIL THAT MEETING AND ABOUT A WEEK AFTER THE INJURY AND JUST AFTER GETTING AN FDA COMPLAINT. WITH ALL MY CONCERNS WITH THIS TECHNOLOGY AND WITH ALL THE QUALITY, MALFUNCTIONING, THE FDA REPORTED INCIDENT, MY INJURY, MY EMPLOYEE'S INJURY, AND NOW THE LEVEL OF DISHONESTY SHOWN. I AM DEEPLY CONCERNED AND IN THE PROCESS OF WITHDRAWING MY NAME ANYWHERE FROM RESPONSIBILITIES AND WHERE I FEEL PRESSURED AND COMPROMISED. I WILL CERTAINLY WITHDRAW MY NAME FROM ANY FDA RESPONSIBILITIES I'VE BEEN ASSIGNED. I'M CONCERNED ABOUT THE QUALITY, MALFUNCTIONING, INJURIES REPORTED, AND DISHONESTY ASSOCIATED WITH IMPLEMENTATION OF THIS DEVICE. I'VE ALSO CONCERNED THAT I AM A SIGNER ON THE FDA AS AN EMPLOYEE AND FEEL AN EXTREME AMOUNT OF PRESSURE TO ENSURE THINGS GO THEIR WAY. I COMPLETELY FEEL COMPROMISED. THE TECHNOLOGY USED FOR THIS PRODUCT IS NOW BEING IMPLEMENTED IN AN OVER THE SHELF CONSUMER DEVICE USED AT HOME THAT IS TO BE SOLD GLOBALLY. THIS INCLUDES DIABETICS, ELDERS, AND OTHERS THAT MAY BE MORE SUSCEPTIBLE TO A SIMILAR INJURY. PEOPLE'S HEALTH MAY BE COMPROMISED ON A LARGER SCALE WITH THIS TECHNOLOGY. CPT CODE 95923 ACROSS THE NATION MAY BE INCREASINGLY REJECTING THIS TYPE OF ELECTRONIC DEVICE TECHNOLOGY DUE TO THIS.