MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-17 for TRACHEOSTOMY CARE KIT 47885 manufactured by Kendall Health Care Products Co..
[19242526]
Trach care brush broke away from handle and lodged in proximal right mainstem bronchus; extended up the trachea within 2 cm of the distal tip of the trach. The pt's wife was performing trach care at home when this occurred. This brush is not intended for use inside the trachea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24348 |
| MDR Report Key | 24348 |
| Date Received | 1995-07-17 |
| Date of Report | 1995-06-05 |
| Date of Event | 1995-05-31 |
| Date Added to Maude | 1995-08-11 |
| 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 | RESPIRATORY THERAPIST |
| 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 | TRACHEOSTOMY CARE KIT |
| Generic Name | TRACHEOSTOMY CARE KIT |
| Product Code | EPE |
| Date Received | 1995-07-17 |
| Catalog Number | 47885 |
| Lot Number | 4126A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 24718 |
| Manufacturer | KENDALL HEALTH CARE PRODUCTS CO. |
| Manufacturer Address | MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-17 |