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MAUDE Adverse Event Report

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WALLY NATURAL PRODUCTS WALLY JOES' EAR CANDLES   Back to Search Results
Event Date 12/10/2007
Event Type  Injury  
Event Description

My boyfriend wanted to try ear candling. I think that these should be banned or at least a very hazardous warning put on packaging. The packaging was all cute. It ended up that the hot wax went down his ear and burnt a hole through his ear drum. The fda needs to get more involved with the selling -or rather non-distribution- of ear candles. These are very dangerous to say the least. Dates of use: one time use and stopped. In 2007. Diagnosis or reason for use: to clear out ear wax.

 
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Brand NameWALLY NATURAL PRODUCTS
Type of DeviceWALLY JOES' EAR CANDLES
Device Event Key940287
MDR Report Key970302
Event Key931113
Report NumberMW5004776
Device Sequence Number1
Product CodeJYH
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 12/20/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/20/2007
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 12/20/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
1,WALLY'S NATURAL EAR CANDLES
 
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