MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-09 for CONING WORKS LLC manufactured by Coning Works, Llc.
[22102964]
Wife has used ear candles for years, which have always sucked an amazing amount of wax from her ears, and never caused a problem. I foolishly consented to have her try this procedure on me, which resulted in melting wax dripping onto my eardrum and burning it. In addition to the burn, i now have wax impacted against my eardrum, affecting my hearing on that side - i didn't have this problem at the outset, and should have left well enough alone-. The pain was extreme, and i will never let her approach me with one of these infernal devices again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017062 |
| MDR Report Key | 1800932 |
| Date Received | 2010-08-09 |
| Date of Report | 2010-08-09 |
| Date of Event | 2010-08-09 |
| Date Added to Maude | 2010-08-18 |
| 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 |
| Brand Name | CONING WORKS LLC |
| Generic Name | EAR CONES |
| Product Code | KCN |
| Date Received | 2010-08-09 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONING WORKS, LLC |
| Manufacturer Address | SEDONA AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-09 |