MAUDE Adverse Event Report: EAR-PIERCING DEVICES; EAR IRRIGATION KIT

Model Number	E80
Health Effect - Clinical Codes	Perforation (2001); Discomfort (2330); Partial Hearing Loss (4472); Ear injury (4921)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: EAR-PIERCING DEVICES
• Common Device Name: EAR IRRIGATION KIT
• MDR Report Key: 23170742
• Report Number: MW5176757
• Device Sequence Number: 9630125
• Product Code: OGQ
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: E80
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMOXICILLIN.; ELECTRIC EAR WAX CLEANER. ; IBUPROFEN.; IRRIGATION FLUSHING SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: American Indian Or Alaskan Native