MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-20 for FOAM EAR DAMS (MINI) * manufactured by Westone.
[1359743]
Ear mold impression were being made for both ears. The procedure was completed without incident on the left ear. The oto dam (foam block) was retained in the right ear canal when the impression was removed. Normally the foam block comes out with the ear impression as it is tied to a removal string. It seems the string tore through the foam block and the block remained in position in the ear canal. ====================== health professional's impression======================the string is threading the top to bottom of the ear foam. However, in examing the package we noted an inconsistency in the manufacturing of these foams. Some strings were threaded only through the edges of some of the foams. I have pictures to submit also showing the quality variance of the foams.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1786989 |
| MDR Report Key | 1786989 |
| Date Received | 2010-07-20 |
| Date of Report | 2010-07-20 |
| Date of Event | 2010-07-08 |
| Report Date | 2010-07-20 |
| Date Reported to FDA | 2010-07-20 |
| Date Added to Maude | 2010-08-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOAM EAR DAMS (MINI) |
| Generic Name | EAR FOAMS |
| Product Code | EWD |
| Date Received | 2010-07-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | PART # 20311 |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTONE |
| Manufacturer Address | 2235 EXECUTIVE DRIVE COLORADO SPRINGS CO 80906 US 80906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-20 |