MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-09-12 for TRACH CARE TRAY STANDARD 47800 manufactured by Tyco/kendall Healthcare.
[429065]
It was reported to tyco healthcare/kendall that a customer experienced a problem with the brush a the tracheostomy care tray. The customer sates "while using the tracheostomy brush that was included in the tracheostomy care tray to clean their trachea, the brush became dislodged from its plastic handle and obstructed their airway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2005-00021 |
| MDR Report Key | 634236 |
| Report Source | 00 |
| Date Received | 2005-09-12 |
| Date of Report | 2005-09-12 |
| Date of Event | 2005-03-31 |
| Date Reported to Mfgr | 2005-09-12 |
| Date Mfgr Received | 2005-09-12 |
| Date Added to Maude | 2005-09-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RAYMOND GAGNON, RN |
| Manufacturer Street | 15 HAMPSHIRE HEALTHCARE |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 2616387 |
| Manufacturer G1 | TYCO/KENDALL HEALTHCARE |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA SUITE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACH CARE TRAY STANDARD |
| Generic Name | TRACHEOSTOMY BRUSH |
| Product Code | LRQ |
| Date Received | 2005-09-12 |
| Model Number | 47800 |
| Catalog Number | 47800 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 623804 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Baseline Brand Name | TRACHEOSTOMY CARE TRAY |
| Baseline Generic Name | TRACH CARE TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 47800 |
| Baseline ID | NA |
| Baseline Device Family | TRACH CARE KIT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K761190 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-09-12 |