MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-10 for 100% BEESWAX EAR CANDLE manufactured by Wally's Natural Products.
[3077355]
I was using an ear candle (name brand wally's 100% beeswax ear candles) as my boyfriend stood by to observe to make sure nothing went wrong. I followed the directions, used a plate to prevent burns, extinguished the first one in a bowl of water next to me. I had done candling before without problems. When i was about half way through candling my left ear, burning hot wax dripped inside my ear. I immediately pulled the candle out, also burning my thumb on the hot wax at the tip of the candle. This immense pain inside of my ear lasted for about thirty minutes before dissipating some. My hearing is completely gone in this ear. I hope that the ear will heal on its own because i do not have insurance and cannot afford to see specialist. I always thought ear candles were safe. I mean, they sell them in the health store! I will never use an ear candle again. Reason for use: ear pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027620 |
| MDR Report Key | 2834755 |
| Date Received | 2012-11-10 |
| Date of Report | 2012-11-10 |
| Date of Event | 2012-11-10 |
| Date Added to Maude | 2012-11-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 100% BEESWAX EAR CANDLE |
| Generic Name | EAR CANDLE |
| Product Code | JYH |
| Date Received | 2012-11-10 |
| Lot Number | 609280300048 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALLY'S NATURAL PRODUCTS |
| Manufacturer Address | P.O. BOX 5275 AUBURN CA 95604 US 95604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-10 |