MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-30 for EAR CANDLE manufactured by Local Health Food Store.
[22125554]
Used "ear candle" from health food store. Wax dripped into my ear causing burning & wax blocked my eardrum. Experienced severe pain & impaired hearing. I used this product per package instructions. Defective product caused hot was to enter my ear canal - burning and blockage resulted. Prescription ear drops 2008. Ear flush performed by rn and z-pack antibiotic prescribed five days later. Out pt surgery to remove blockage in the same month. Dose or amount: 1 candle per ear. Frequency: once. Route: dates of use: 2008. (1 time only). Reason for use: clean ears. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009478 |
| MDR Report Key | 1276183 |
| Date Received | 2008-12-30 |
| Date of Report | 2008-12-30 |
| Date of Event | 2008-12-07 |
| Date Added to Maude | 2009-01-15 |
| 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 |
| Generic Name | EAR CANDLE |
| Product Code | JYH |
| Date Received | 2008-12-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LOCAL HEALTH FOOD STORE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2008-12-30 |