MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-20 for WALLY NATURAL PRODUCTS manufactured by .
[753748]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004776 |
| MDR Report Key | 970302 |
| Date Received | 2007-12-20 |
| Date of Report | 2007-12-20 |
| Date of Event | 2007-12-10 |
| Date Added to Maude | 2008-01-02 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | WALLY NATURAL PRODUCTS |
| Generic Name | WALLY JOES' EAR CANDLES |
| Product Code | JYH |
| Date Received | 2007-12-20 |
| Returned To Mfg | 2007-12-20 |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 940287 |
| Manufacturer Address | AUBURN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-20 |