BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR-PIERCING DEVICES

    MDR report key: 23170742 · Received September 29, 2025

    Report

    Report Number
    MW5176757
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 19, 2025
    Report Date
    September 25, 2025
    Manufacturer
    UNK
    Product Code
    OGQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772983 EAR-PIERCING DEVICES EAR IRRIGATION KIT OGQ UNK E80

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other AMOXICILLIN.| ELECTRIC EAR WAX CLEANER. | IBUPROFEN.| IRRIGATION FLUSHING SYSTEM.