MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-01 for BLOM-SINGER BE2018 manufactured by Inhealth Technologies.
[18967]
Pt aspirated a voice prosthesis after trying to remove it herself. Physician removal by broncoscope was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26505 |
| MDR Report Key | 26505 |
| Date Received | 1995-08-01 |
| Date of Report | 1995-03-03 |
| Date of Event | 1995-02-21 |
| Date Facility Aware | 1995-02-21 |
| Report Date | 1995-03-03 |
| Date Reported to Mfgr | 1995-03-03 |
| Date Added to Maude | 1995-10-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BLOM-SINGER |
| Generic Name | IN-DWELLING LOW PRESSURE VOICE PROSTHESIS |
| Product Code | MCK |
| Date Received | 1995-08-01 |
| Catalog Number | BE2018 |
| ID Number | SIZE 1.8 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27203 |
| Manufacturer | INHEALTH TECHNOLOGIES |
| Manufacturer Address | 301 S 20TH ST BIRMINGHAM AL 352330001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-08-01 |