MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-30 for OTO-EASE SINGLE DOSE UNITS 540174 manufactured by Westone.
[18977596]
Child was diagnosed by ent to have fungus in ears. Dates of use: (b)(6) 2012. Reason for use: lubricant swimming plugs for insertion into ears.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026361 |
| MDR Report Key | 2680490 |
| Date Received | 2012-07-30 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-05-31 |
| Date Added to Maude | 2012-08-06 |
| 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 |
| 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 | OTO-EASE SINGLE DOSE UNITS |
| Generic Name | EAR LUBRICANT |
| Product Code | EWD |
| Date Received | 2012-07-30 |
| Catalog Number | 540174 |
| Lot Number | PART# 54017 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-07-30 |