MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-13 for PARAFFIN EAR CANDLE manufactured by .
[5808758]
I purchased paraffin wax candles from (b)(6) and used two on my left ear. I let the second candle burn slightly more than half way because i wasn't noticing any results. When i got up i found my hearing had become much worse and the inside of my ear was covered/filled with chalk like but sticky wax residue from the candle. My ear is in pain and i can hardly hear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043159 |
| MDR Report Key | 4856429 |
| Date Received | 2015-06-13 |
| Date of Report | 2015-06-13 |
| Date of Event | 2015-06-13 |
| Date Added to Maude | 2015-06-22 |
| 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 | 0 |
| 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 | PARAFFIN EAR CANDLE |
| Generic Name | PARAFFIN EAR CANDLE |
| Product Code | JYH |
| Date Received | 2015-06-13 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-13 |