MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-02 for PINK SILICAST UNK manufactured by Westone.
[88929]
Pt was being fitted for a hearing aid. Upon being removed from the right ear, the earmold impression broke, leaving part of the material in the pt's right external ear canal. The remaining material was unsuccessfully removed under microscope. The foreign body was subsequently removed from the right external ear canal surgically.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 146273 |
| MDR Report Key | 146273 |
| Date Received | 1998-01-02 |
| Date of Report | 1997-11-21 |
| Date of Event | 1997-11-13 |
| Date Facility Aware | 1997-11-19 |
| Report Date | 1997-11-21 |
| Date Reported to Mfgr | 1997-11-21 |
| Date Added to Maude | 1998-02-02 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | PINK SILICAST |
| Generic Name | EARMOLD IMPRESSION MATERIAL |
| Product Code | LDG |
| Date Received | 1998-01-02 |
| Model Number | PINK SILICAST |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 142573 |
| Manufacturer | WESTONE |
| Manufacturer Address | 2235 EXECUTIVE CIRCLE COLORADO SPRINGS CO 80906 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-01-02 |