MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-07 for CURITY TRACHEOSTOMY KIT 47800 manufactured by Kendall Healthcare Products Co..
[20239049]
Tracheostomy cleaning brush broke off at handle while doing tracheostomy care. Brush separated at point where wire engages plastic tip. Brush was retrieved from tracheostomy tube with tweezers. No consequence to pt. A sample from same lot was returned to the mfr for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015115 |
| MDR Report Key | 200571 |
| Date Received | 1998-12-07 |
| Date of Report | 1998-12-07 |
| Date of Event | 1998-12-03 |
| Date Added to Maude | 1998-12-09 |
| 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 | CURITY TRACHEOSTOMY KIT |
| Generic Name | TRACHEOSTOMY CARE KIT |
| Product Code | LRQ |
| Date Received | 1998-12-07 |
| Model Number | NA |
| Catalog Number | 47800 |
| Lot Number | HE0701KG |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 194829 |
| Manufacturer | KENDALL HEALTHCARE PRODUCTS CO. |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 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 | 1998-12-07 |