MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-27 for EAR CANDLE manufactured by Unk.
[1799999]
Ear candling 09/10 and 10/10 by (b)(6). Remnants of the ear candle wax impacted right eardrum, restricting movement of the eardrum and causing inflammation of the surrounding area. Owners of (b)(6) refused to provide any insurance info. Another customer had the wax drip into her ear and complained of a burn in the ear. When i called them, they said to come in and kim wells put me in a foot bath that she claimed pulled toxins from all major organs of the body and said, it would help relieve the pressure in my ears. I then went to seek medical help from a licensed physician who said to stay away from them and report what happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018334 |
| MDR Report Key | 1916499 |
| Date Received | 2010-11-27 |
| Date of Report | 2010-11-27 |
| Date of Event | 2010-10-09 |
| Date Added to Maude | 2010-12-09 |
| 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 | 0 |
| 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 |
| Generic Name | EAR CANDLE |
| Product Code | JYH |
| Date Received | 2010-11-27 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-27 |