Description of Event or Problem · 0
DEAR FDA MEDICAL DEVICE REPORTING TEAM, I AM WRITING TO YOU AS A MEDICAL PROFESSIONAL TO EXPRESS SERIOUS CONCERN REGARDING A WRIST-TYPE BLOOD PRESSURE MONITOR THAT IS BEING WIDELY SOLD ON AMAZON. I HAVE NO PERSONAL DISPUTE WITH THE MANUFACTURER OR SELLER; HOWEVER, I BELIEVE THIS DEVICE POSES A CLEAR AND IMMEDIATE RISK TO PUBLIC HEALTH. MY CONCERN IS BASED ON DIRECT CLINICAL OBSERVATIONS. SEVERAL OF MY PATIENTS HAVE BROUGHT THIS SPECIFIC DEVICE TO THEIR MEDICAL APPOINTMENTS, AND IN NEARLY EVERY CASE, THE READINGS OBTAINED FROM IT HAVE BEEN INACCURATE OR INCONSISTENT WHEN COMPARED WITH VALIDATED CLINICAL-GRADE MONITORS. THIS ISSUE IS ESPECIALLY EVIDENT AMONG ELDERLY AND HYPERTENSIVE PATIENTS, WHO OFTEN RELY HEAVILY ON HOME MONITORING FOR BLOOD PRESSURE MANAGEMENT. AFTER LEARNING THAT THIS PRODUCT'S MONTHLY SALES ON AMAZON EXCEED 7,000 UNITSHTTPS://WWW.AMAZON.COM/PRESSURE-RECHARGEABLE-ADJUSTABLE-AUTOMATIC-BROADCAST/DP/B0DPLYX26V, IT BECAME APPARENT THAT MANY OF THESE PATIENTS MOST LIKELY PURCHASED THE SAME DEVICE FROM THAT MARKETPLACE. THIS WIDESPREAD DISTRIBUTION SIGNIFICANTLY AMPLIFIES THE POTENTIAL PUBLIC HEALTH IMPACT OF THE INACCURACIES OBSERVED. WRIST-TYPE MONITORS ARE INHERENTLY SENSITIVE TO BODY POSITION AND POSTURE, AND WITHOUT PROPER PROFESSIONAL GUIDANCE, USERS ARE HIGHLY LIKELY TO OBTAIN ERRONEOUS READINGS. UNFORTUNATELY, THE PRODUCT'S MARKETING MATERIALS FAIL TO EMPHASIZE THIS CRITICAL LIMITATION, WHICH CAN EASILY GIVE CONSUMERS A FALSE SENSE OF ACCURACY AND SAFETY. THE FORESEEABLE RISK IS SEVERE: A HYPERTENSIVE PATIENT MAY DISCONTINUE OR ALTER PRESCRIBED MEDICATION BASED ON FALSELY LOW READINGS FROM THIS DEVICE, POTENTIALLY LEADING TO UNCONTROLLED HYPERTENSION, STROKE, HEART ATTACK, OR OTHER LIFE-THREATENING EVENTS. CLINICAL DECISIONS BASED ON SUCH UNRELIABLE DATA COULD HAVE FATAL CONSEQUENCES. EVEN MORE CONCERNING, I HAVE FOUND EVIDENCE SUGGESTING POSSIBLE FRAUDULENT ACTIVITY. WHILE THE FDA'S PUBLIC DATABASE LISTS A REGISTERED MODEL NUMBER UNDER THIS BRAND (W1101L), THE PRODUCT RECEIVED BY PATIENTS SHOWS NO MANUFACTURER INFORMATION OR MODEL NUMBER ANYWHERE ON THE PACKAGING. THIS COMPLETE ABSENCE OF BASIC IDENTIFICATION INFORMATION RAISES SERIOUS REGULATORY CONCERNS AND STRONGLY SUGGESTS THAT THE SELLER ON AMAZON MAY BE DISTRIBUTING UNAUTHORIZED OR COUNTERFEIT MEDICAL DEVICES. SUCH CONDUCT IS UNACCEPTABLE AND MAY CONSTITUTE A VIOLATION OF U.S. MEDICAL DEVICE REGULATIONS. GIVEN THESE CIRCUMSTANCES, I URGENTLY REQUEST THAT THE FDA INVESTIGATE WHETHER THIS PRODUCT INVOLVES THE MISUSE OR OMISSION OF REQUIRED REGISTRATION AND LABELING INFORMATION. IF FRAUDULENT OR UNAUTHORIZED ACTIVITIES ARE CONFIRMED, I RESPECTFULLY URGE THE FDA TO TAKE IMMEDIATE ENFORCEMENT ACTION TO REMOVE THIS PRODUCT FROM AMAZON AND OTHER SALES CHANNELS TO PREVENT FURTHER HARM TO CONSUMERS. PUBLIC SAFETY MUST NOT BE COMPROMISED FOR COMMERCIAL CONVENIENCE. THANK YOU FOR YOUR ATTENTION TO THIS URGENT MATTER. SINCERELY, (B)(6).