MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-20 for BLOM SINGER LOW PRESSURE VOICE PROSTHESIS 512C22 BE6011 manufactured by Intl Healthcare Technologies.
[18833150]
Pt came to the hosp emergency department because the medical device being reported had come out of her tracheal stoma. As the respiratory therapist and ed physician were attempting to re-insert and attach the device the pt inhaled and aspirated the device into her lungs. She began coughing but could not expectorate the device. An emergency bronchoscopy was done to retrieve the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007729 |
| MDR Report Key | 28181 |
| Date Received | 1995-11-20 |
| Date of Report | 1995-11-16 |
| Date of Event | 1995-11-15 |
| Date Added to Maude | 1995-11-22 |
| 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 |
| 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 | BLOM SINGER LOW PRESSURE VOICE PROSTHESIS |
| Generic Name | VOICE PROSTHESIS |
| Product Code | MCK |
| Date Received | 1995-11-20 |
| Model Number | 512C22 |
| Catalog Number | BE6011 |
| Lot Number | 536258 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29104 |
| Manufacturer | INTL HEALTHCARE TECHNOLOGIES |
| Manufacturer Address | CARPINTERIA CA 930132918 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1995-11-20 |