MAUDE Adverse Event Report: HEIFENG ZHIZAO (SHENZHEN) TECHNOLOGY CO.,LTD BEBIRD R1; OTOSCOPE

Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This bebird r1 wax removal tool for ear straight up blew up on me the second time i charged it.This morning i had it sitting on the little shelf by the bathroom sink charging, i was just finishing up shaving (like 3 mins) and i started smelling something burnt.When i unplugged it, it popped and caught fire right there.The back of my hand got burned, i just came back from urgent care where they wrapped it up.Here's the info: order #: (b)(6).Product: bebird r1 wax removal tool for ear - spade ear canal cleaner with camera 1080p earscope, wax remove ear picker with vari replacement tips, camera with 6led light for ear/nose/throat examination, black seller: bebird official us link: https://www.Amazon.Com/dp/ b08m9g18h3?ref_=ppx_hzod _title_dt_b_fed_asin_title_0_1 this isn¿t just a quality issue, it's a straight safety hazard.I need this reported to your safety team, not just tossed in as a normal refund thing.

• Brand Name: BEBIRD R1
• Common Device Name: OTOSCOPE
• Manufacturer (Section D): HEIFENG ZHIZAO (SHENZHEN) TECHNOLOGY CO.,LTD
• MDR Report Key: 23615941
• Report Number: MW5179214
• Device Sequence Number: 18332985
• Product Code: ERA
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Race: White