Description of Event or Problem · 0
TO THE FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) AND THE MEDWATCH PROGRAM, I AM A CONSUMER WHO RECENTLY PURCHASED THE FOTOSY WRIST BLOOD PRESSURE MONITOR (ASIN: B0DPLYX26V, HTTPS://WWW.AMAZON.COM/PRESSURE-RECHARGEABLE-ADJUSTABLE-AUTOMATIC-BROADCAST/DP/B0DPLYX26V) ON AMAZON. AFTER BRIEF USE, I DISCOVERED THAT THE PRODUCT DESCRIPTION IS SEVERELY MISLEADING, AND I PERSONALLY EXPERIENCED A SAFETY SCARE THAT COULD HAVE RESULTED IN PHYSICAL INJURY. I AM CONVINCED THAT THIS PRODUCT POSES A SIGNIFICANT THREAT TO THE PUBLIC, AND I AM FILING THIS URGENT REPORT. 1. FIRSTHAND SAFETY INCIDENT: "CONVENIENCE" IN DESCRIPTION BECAME "DANGER" IN REALITY I PURCHASED THIS DEVICE BECAUSE OF ITS ADVERTISED "PORTABLE AND RECHARGEABLE" FEATURES, HOPING TO CONVENIENTLY MONITOR MY BLOOD PRESSURE. HOWEVER, DURING NORMAL USE (NOT CHARGING), THE DEVICE SUDDENLY BEGAN TO OVERHEAT FROM THE BOTTOM. THE TEMPERATURE RAPIDLY INCREASED TO THE POINT WHERE I HAD TO RIP IT OFF MY WRIST. THE PLASTIC CASING VISIBLY WARPED AND SOFTENED DUE TO THE HEAT, EMITTING A STRONG, PUNGENT CHEMICAL SMELL. THIS REALITY IS IN STARK CONTRAST TO THE "SAFE AND EASY-TO-USE" IMAGE PORTRAYED ON THE PRODUCT PAGE. A RECHARGEABLE DEVICE THAT PROMISES TO "ELIMINATE TEDIOUS BATTERY REPLACEMENTS" SUFFERED A CATASTROPHIC FAILURE IN ITS CORE--THE BATTERY SYSTEM--DURING NORMAL OPERATION. THIS INDICATES A FUNDAMENTAL DESIGN OR MANUFACTURING DEFECT. I WAS FORTUNATE TO REACT QUICKLY; OTHERWISE, I COULD HAVE SUFFERED SERIOUS BURNS OR CAUSED A FIRE. THE "HEALTH MONITORING DEVICE" I PURCHASED NEARLY BECAME A "LETHAL WEAPON." 2. DECEPTIVE AND MISLEADING PRODUCT DESCRIPTION AFTER MY FRIGHTENING EXPERIENCE, I RE-EXAMINED THE PRODUCT PAGE AND IDENTIFIED MULTIPLE DECEPTIVE CLAIMS: UNSUBSTANTIATED "ACCURACY" CLAIMS: THE PAGE CLAIMS, "ACCURATE MEASUREMENT," BUT IT DOES NOT PROVIDE AN FDA APPROVAL NUMBER, CLEARANCE CODE, OR REFERENCE TO INDEPENDENT CLINICAL VALIDATION. AS A PURCHASER, I HAVE NO TRUST IN ITS ACCURACY. A DEVICE THAT CANNOT GUARANTEE BASIC SAFETY CANNOT POSSIBLY BE "ACCURATE." DANGEROUS MARKETING TO HIGH-RISK GROUPS: THE DEVICE EMPHASIZES ITS VOICE FUNCTION AS "IDEAL FOR ELDERLY PEOPLE WITH POOR EYESIGHT." THE THOUGHT OF MY ELDERLY PARENTS USING THIS, POTENTIALLY UNABLE TO REACT AS QUICKLY AS I DID, IS TERRIFYING. THIS IS PACKAGING A "LETHAL RISK" WITH A "CONVENIENT FEATURE." MEDICALLY DEFICIENT DESIGN: ITS MEMORY FUNCTION LACKS A TIMESTAMP, MAKING IT EXCEEDINGLY DIFFICULT TO TRACK BLOOD PRESSURE TRENDS EFFECTIVELY. THIS FAILS TO MEET THE BASIC REQUIREMENTS OF A MEDICAL MONITORING DEVICE. THE MOST CRITICAL FLAW: COMPLETE LACK OF COMPLIANCE INFORMATION: NOWHERE ON THE PRODUCT PAGE OR ON THE PHYSICAL PACKAGING I RECEIVED COULD I FIND AN FDA REGISTRATION/LISTING NUMBER OR CLEAR LICENSED INFORMATION. AS A CONSUMER, I HAVE THE RIGHT TO KNOW IF THE MEDICAL DEVICE I AM USING IS LEGAL. THE COMPLETE ABSENCE OF THIS MANDATORY INFORMATION STRONGLY SUGGESTS THAT THE PRODUCT IS AN UNAUTHORIZED, ILLEGALLY MARKETED MEDICAL DEVICE. 3. MY REQUEST AS AN AFFECTED CONSUMER AS A CONSUMER WHO WAS NEARLY INJURED, I CANNOT STAND BY WHILE THIS DANGEROUS PRODUCT CONTINUES TO BE SOLD TO THOUSANDS OF FAMILIES ON AMAZON. GIVEN MY EXPERIENCE WITH THE BATTERY THERMAL RUNAWAY EVENT, I URGENTLY REQUEST AMAZON TO IMMEDIATELY SUSPEND THE SALE OF THIS PRODUCT TO PREVENT FURTHER PHYSICAL HARM AND PROPERTY DAMAGE TO OTHER CONSUMERS. IF IT IS CONFIRMED TO BE ILLEGALLY MARKETED, I ASK THAT STRONG ENFORCEMENT ACTION BE TAKEN AGAINST THE RESPONSIBLE PARTIES AND THAT A PUBLIC WARNING BE ISSUED TO THOSE WHO HAVE ALREADY PURCHASED IT. SINCERELY, (B)(6).