MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-15 for OTO-EASE EAR LUBRICANT manufactured by Westone.
[2726459]
A family brought oto-ease ear lubricant back to the audiology clinic after noting that the lubricant appeared to be contaminated with a black fuzzy substance. Lubricant cultured and noted to be contaminated with 5 different microorganisms, including a type of mold. Thirteen other bottles of oto-ease (some already opened, others were sealed bottles) were cultured and two of those bottles were positive for microorganisms. Some bottles had a lot number of "pdwt," others did not have a lot number. No exp dates were listed on the bottles. See attached grid which summarizes findings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025846 |
| MDR Report Key | 2622823 |
| Date Received | 2012-06-15 |
| Date of Report | 2012-06-06 |
| Date of Event | 2012-04-27 |
| Date Added to Maude | 2012-06-21 |
| 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 | RISK MANAGER |
| 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 EAR LUBRICANT |
| Generic Name | EAR LUBRICANT |
| Product Code | EWD |
| Date Received | 2012-06-15 |
| Lot Number | PDWT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTONE |
| Manufacturer Address | 2235 EXECUTIVE CIRCLE COLORADO SPRINGS CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-15 |