MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-12 for LEE'S * manufactured by Lee's Candles Inc.
[19488333]
Rptr is giving the source of ear wax candles. Rptr has no complaint other than that ear wax candles are dangerous to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003288 |
| MDR Report Key | 396380 |
| Date Received | 2002-04-12 |
| Date Added to Maude | 2002-05-29 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEE'S |
| Generic Name | EAR CANDLES |
| Product Code | JYH |
| Date Received | 2002-04-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 385409 |
| Manufacturer | LEE'S CANDLES INC |
| Manufacturer Address | 5734 SKY COUNTY SAN ANTONIO TX 78247 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-12 |