MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-04 for WESTONE UNK manufactured by Westone.
[20884653]
Rptr had an impression taken for a new earmold for their hearing aid. The impression material could not be removed without considerable effort, and led to significant pain, and bleeding inside their ear. Rptr had not reacted to impression material made by other companies. This was the first time this material was used to take an impression.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032932 |
| MDR Report Key | 549967 |
| Date Received | 2004-08-04 |
| Date of Report | 2004-08-04 |
| Date of Event | 2004-06-08 |
| Date Added to Maude | 2004-10-21 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WESTONE |
| Generic Name | EARMOLD IMPRESSION MATERIAL |
| Product Code | EWD |
| Date Received | 2004-08-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 539485 |
| Manufacturer | WESTONE |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2004-08-04 |