MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-21 for FERRARIS 022454 * manufactured by Ferraris Respiratory.
[17486939]
During diffusion test, pt inhaled fast and deep and started to cough uncontrollably. Pt coughed up a small (~3/4"x ~1/2cm)piece of plastic which came from the inside of the patient filter on the mouth piece. Pulmonary function test continued with different mouthpiece and filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 701115 |
| MDR Report Key | 701115 |
| Date Received | 2006-02-21 |
| Date of Report | 2006-02-21 |
| Date of Event | 2006-02-10 |
| Report Date | 2006-02-21 |
| Date Reported to FDA | 2006-02-21 |
| Date Added to Maude | 2006-04-20 |
| 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 | FERRARIS |
| Generic Name | MOUTHPIECE, FILTER, PULMONARY FUNCTION TESTING |
| Product Code | BZC |
| Date Received | 2006-02-21 |
| Model Number | 022454 |
| Catalog Number | * |
| Lot Number | 051705 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 690210 |
| Manufacturer | FERRARIS RESPIRATORY |
| Manufacturer Address | 901 FRONT STREET LOUISVILLE CO 80027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-21 |