EAR-PIERCING DEVICES

Description of Event or Problem

DEAR FDA, WHICH I PURCHASED ON AMAZON FROM THE SELLER (B)(6) KAUGIC EAR WAX REMOVAL KIT, MANUAL EAR CLEANER WITH 7M WATER PRESSURE & SOFT SILICONE TIP, SAFE EAR CLEANING TOOL, FSA HSA ELIGIBLE PRODUCT LINK: HTTPS://WWW.AMAZON.COM/DP/B0DZHKYTFJ ORDER PLACED (B)(6) 2025 ORDER # (B)(6) ON (B)(6) 2025, I USED THIS DEVICE FOR THE SECOND TIME TO IRRIGATE MY EARS. I DID NOT EXPECT THE WATER PRESSURE FROM THE NOZZLE TO BE SO STRONG. THE HIGH-PRESSURE STREAM PERFORATED MY LEFT EARDRUM, CAUSING IMMEDIATE HEARING LOSS IN THAT EAR. I AM CURRENTLY EXPERIENCING SIGNIFICANT DISCOMFORT. IT APPEARS THAT THIS PRODUCT IS A PROFESSIONAL MEDICAL DEVICE THAT REQUIRES FDA AUTHORIZATION FOR USE IN MEDICAL INSTITUTIONS. HOWEVER, THE SELLER HAS MARKETED IT AS SUITABLE FOR HOME USE AND HAS SOLD IT WITHOUT THE PROPER AUTHORIZATION FOR A PROFESSIONAL MEDICAL DEVICE. THIS UNAUTHORIZED SALE DIRECTLY RESULTED IN MY INJURY. I HAVE ATTACHED RELEVANT MEDICAL RECORDS AND BILLS DOCUMENTING THE INJURY AND TREATMENT. I REQUEST THAT THE FDA INVESTIGATE THIS PRODUCT, DETERMINE WHETHER IT COMPLIES WITH U.S. SAFETY AND AUTHORIZATION STANDARDS, AND TAKE APPROPRIATE ACTION TO PREVENT FURTHER HARM TO CONSUMERS. THANK YOU FOR YOUR URGENT ATTENTION TO THIS MATTER.