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U.S. Department of Health and Human Services

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

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EAR CANDLES; TAPE AND BANDAGE, ADHESIVE Back to Search Results
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.
 
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Brand Name
EAR CANDLES
Type of Device
TAPE AND BANDAGE, ADHESIVE
MDR Report Key11337692
MDR Text Key232622235
Report NumberMW5099432
Device Sequence Number1
Product Code KGX
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received02/16/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
Patient Weight99
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