MAUDE Adverse Event Report: EAR CANDLES; TAPE AND BANDAGE, ADHESIVE

Device Problems Patient-Device Incompatibility (2682); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Hearing Loss (1882); Burn, Thermal (2530)

Event Date 02/11/2021

Event Type  Injury  

Event Description

Lost hearing; was using ear candles sold at a local granary store in (b)(6) that have no burn line and came with no instructions by the way.Hot wax dropped in my ear burning my inner ear.Lost partial hearing in my right ear if it does not come back in a few days i will go to doctor.I am not sure if it melted the wax and clogged up my ear canal or perforated my ear drum or what but it hurts and these should be outlawed.

• Brand Name: EAR CANDLES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 11337692
• MDR Text Key: 232622235
• Report Number: MW5099432
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 99