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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EAR CANDLE
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EAR CANDLE Back to Search Results
Health Effect - Clinical Codes Inflammation (1932); Pain (1994)
Date of Event 05/16/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A (b)(6) year old female presented with ear pain resulting from use of ear candling; mild inflammation of the ear canal.Is the product over-the-counter: yes.Event abated after use stopped or dose reduced: yes.
 
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Brand Name
EAR CANDLE
Common Device Name
EAR CANDLE
MDR Report Key6604693
Report NumberMW5070129
Device Sequence Number1156026
Product Code JYT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/18/2017
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
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/18/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age4 YR
Patient Weight18
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