NEUROCARE PRO BRAIN CAP 280

Description of Event or Problem

THE PATIENT IS AN 87-YEAR-OLD FEMALE, WHO USED AN FDA REGISTERED POSSIBLE 510(K) MEDICAL DEVICE- FOR RED LIGHT THERAPY AND NEAR INFRARED LIGHT THERAPY AS DIRECTED. THE PRODUCT WAS FOUND ONLINE AND PROMOTED BY TBI ANALYTICS AS EFFECTIVE FOR TRAUMATIC BRAIN INJURY. THE DEVICE WAS APPLIED TO THE HEAD AS DIRECTED. IT WAS TURNED ON TO THE APPROPRIATE FREQUENCY AND IMMEDIATELY THE DEVICE BEGAN TO HEAT UP. IT'S ADVERTISED AS "NON-THERMAL". HOWEVER, 15 MINUTES INTO THE TREATMENT THE PATIENT EYE STARTED TO BLEED. THE DEVICE WAS TURNED OFF AND WE APPLIED A COLD COMPRESS TO THE EYE. SHE WAS TRANSPORTED TO THE EMERGENCY CLINIC. SHE WAS DIAGNOSED WITH CORNEAL STAINING. THE DEVICE IS CALLED NEUROCARE PRO BRAIN CAP 280. IT'S ADVERTISED AS A MEDICAL DEVICE WITH ADVANCED SMD MICROCHIPS, WITH 2 POWERFUL AND EFFICIENT DIODES, IN EACH CHIP SET FOR BOTH NEAR INFRARED LIGHT 850 AND RED LIGHT AT 620 NM LIGHT FREQUENCY ON EVERY CHIP SE DELIVERING POLYCHROMATIC. THE REALITY FROM THE FORENSICS ON THE DEVICE IS THAT IT HAS NONE OF THE CLAIMED TECHNOLOGY. THE PRODUCT IS ADVERTISED AS MANUFACTURED BY NEUROCAREPRO AND DISTRIBUTED BY NEUROCARE PRO. THE MEDICAL GRADE TECHNOLOGY DOESN'T EXIST IN THE EITHER THE MAT OR THE CONTROLLER FREQUENCY. THERMAL CORNEAL BURNS HAPPENED BECAUSE THERMAL HEATING FROM POOR DESIGN (NO THERMAL CUTOFF, INADEQUATE WIRE GAUGE, IN INSULATION AGAINST HEAT BUILDUP.) THERE IS NO UDI ON THE PRODUCT: THERE IS A COMPANY NAME AND MANUFACTURER. THERE IS NO NAME OF THE MEDICAL DEVICE, THERE IS NO CATALOG NUMBER, THERE IS NO PRODUCTION IDENTIFIER LOT NUMBER, THERE IS NO CUSTOMER CONTACT INFORMATION, NO BAR CODES, NOTHING THAT TRACES THIS PRODUCT BACK TO A SPECIFIC TYPE OF MANUFACTURING. I TRIED TO UPLOAD PICTURES FOR YOU BUT THE FEATURE IS NOT WORKING IN THIS COMPLAINT FORM.