Description of Event or Problem · 0
PRODUCT NAME: AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR BRAND: AUVON MANUFACTURER: SHENZHEN AS TEC TECHNOLOGY CO LTD MODEL NUMBER: AS1080 510K NUMBER: K143268 PLACE OF PURCHASE: AMAZON (ORDER ID: (B)(6)) ASIN: (B)(6) PRODUCT LINK: HTTPS://WWW.AMAZON.COM/DP/B06ZZ19MS3 I AM WRITING TO REPORT AN ADVERSE EVENT RELATED TO THE TENS UNIT (MODEL: AS8010) I PURCHASED FROM AMAZON ON (B)(6) 2024. THE PRODUCT'S 510K NUMBER IS K143268, AND IT WAS USED FOR PERSONAL PHYSICAL THERAPY. I HAVE USED THE DEVICE SEVERAL TIMES WITHOUT ANY ISSUES, BUT RECENTLY, I DECIDED TO APPLY IT TO MY UPPER ARM. I HAD USED THE TENS UNIT ON MY LOWER BACK AND LEGS PREVIOUSLY WITHOUT ANY PROBLEMS. ON [(B)(6) 2025], I APPLIED THE ELECTRODES TO MY UPPER ARM AS INSTRUCTED BY THE USER MANUAL. DURING THE TREATMENT, I EXPERIENCED A SHARP, BURNING SENSATION IN MY UPPER ARM. THE INTENSITY OF THE ELECTRICAL STIMULATION WAS SET AT A MODERATE LEVEL, BUT THE PAIN WAS SEVERE AND UNEXPECTED. AFTER REMOVING THE ELECTRODES, I NOTICED REDNESS AND IRRITATION ON THE SKIN. THE SKIN APPEARED TO BE SLIGHTLY BURNED AND REMAINED SENSITIVE FOR SEVERAL DAYS. I HAVE ATTACHED PHOTOS OF THE AFFECTED AREA FOR YOUR REFERENCE. ADDITIONAL INFORMATION: 510K NUMBER CONCERNS: THE 510K NUMBER K143268 LISTED ON THE PRODUCT APPEARS TO BE NON-COMPLIANT AND MAY CONTAIN IRRELEVANT OR INCORRECT INFORMATION. UPON REVIEWING THE FDA WEBSITE, I FOUND THAT K143268 INCLUDES A WIDE RANGE OF OTHER PRODUCT MODELS, WHICH SUGGESTS THAT THE MANUFACTURER MIGHT BE USING THIS K NUMBER TO COVER MULTIPLE DEVICES WITHOUT PROPER INDIVIDUAL APPROVAL. THIS PRACTICE CAN BE MISLEADING AND POTENTIALLY DANGEROUS FOR CONSUMERS, AS IT MAY INDICATE THAT THE DEVICE HAS NOT BEEN THOROUGHLY REVIEWED AND APPROVED FOR SAFETY AND EFFECTIVENESS. MANUFACTURER: SHENZHEN AS TEC TECHNOLOGY CO LTD I CONTACTED THE SELLER ON AMAZON, BUT THEY WERE NOT RESPONSIVE TO MY CONCERNS. I BELIEVE THAT THE TENS UNIT I PURCHASED IS DEFECTIVE AND POTENTIALLY UNSAFE FOR USE. THE 510K NUMBER K143268 APPEARS TO BE NON-COMPLIANT, AND THE LACK OF SPECIFIC WARNINGS IN THE USER MANUAL IS CONCERNING. I AM SUBMITTING THIS REPORT TO THE FDA TO ENSURE THAT THIS PRODUCT IS THOROUGHLY INVESTIGATED AND THAT OTHER CONSUMERS ARE PROTECTED FROM SIMILAR INCIDENTS. THANK YOU FOR YOUR ATTENTION TO THIS MATTER. SINCERELY.