MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-10 for EARWAX CANDLE UNK manufactured by *.
[20344843]
This product was advertized to cure sinusitis and clean earwax. Product is mislabeled and fda needs to investigate. This product is a fraud. Patient was burnt from using this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005889 |
| MDR Report Key | 1013928 |
| Date Received | 2007-08-10 |
| Date of Report | 2007-08-10 |
| Date Added to Maude | 2008-03-27 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EARWAX CANDLE |
| Generic Name | NONE |
| Product Code | JYH |
| Date Received | 2007-08-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 985889 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-08-10 |