MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-02 for OTO-EASE manufactured by Westone Laboratories, Inc..
[15022618]
Used oto-ease and had unusual nose, ear and eye infections. Dates of use: (b)(6) 2011 - (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026401 |
| MDR Report Key | 2686927 |
| Date Received | 2012-08-02 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-04-20 |
| Date Added to Maude | 2012-08-09 |
| 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 | 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 |
| Generic Name | OTO-EASE |
| Product Code | EWD |
| Date Received | 2012-08-02 |
| ID Number | NA |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTONE LABORATORIES, INC. |
| Manufacturer Address | 2235 EXECUTIVE CIRCLE COLORADO SPRINGS CO 80906 US 80906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-02 |