MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-24 for EAR CANDLE manufactured by .
[21649694]
I was getting ear candling done for the first time and the first side (left ear) went fine. On the right side, after 5 minutes, the candle exploded in my ear and i started screaming. The aesthetician became obviously upset and uncomfortable and told me this never happens. She cleaned my ear, put a paste for burn victims in it and gave me a cream to take home and apply. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020721 |
| MDR Report Key | 2108051 |
| Date Received | 2011-05-24 |
| Date of Report | 2011-05-24 |
| Date of Event | 2011-05-20 |
| Date Added to Maude | 2011-05-31 |
| 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 | EAR CANDLE |
| Generic Name | BEES WAX |
| Product Code | JYH |
| Date Received | 2011-05-24 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-05-24 |