MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-26 for EAR CANDLE manufactured by .
[4008780]
Pt's mother was using an ear candle to help with pain to the pt's ear. The wick of the candle fell into the child's right ear causing 2nd degree burn to the lobe and outer canal. The tm and internal canal is spared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033177 |
| MDR Report Key | 3496768 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-11-25 |
| Date Added to Maude | 2013-12-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2013-11-26 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-11-26 |