MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-09-23 for KENDALL * 47899 manufactured by Tyco Healthcare/kendall.
[268208]
It was reported to tycohealthcare/kendall on 9/13/02 that a customer had a problem with a trach brush. The customer states that the patient was using the trach cleaning brush in the kit to clear the inner cannula while the trach tube was still in the patient. The patient inserted the brush and lost the brush down the trachea. The patient required surgery for removal of the cleaning brush from the lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2002-00009 |
| MDR Report Key | 420008 |
| Report Source | 05,07 |
| Date Received | 2002-09-23 |
| Date of Report | 2002-09-19 |
| Date of Event | 2002-08-12 |
| Date Facility Aware | 2002-08-12 |
| Report Date | 2002-09-16 |
| Date Reported to Mfgr | 2002-09-13 |
| Date Mfgr Received | 2002-09-13 |
| Date Added to Maude | 2002-10-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARTHA PORTNOW RN |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618547 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | BASIC TRACH CARE SET |
| Product Code | EPE |
| Date Received | 2002-09-23 |
| Model Number | * |
| Catalog Number | 47899 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 409064 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US |
| Baseline Brand Name | KENDALL |
| Baseline Generic Name | BASIC TRACH CARE SET |
| Baseline Model No | * |
| Baseline Catalog No | 47899 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-09-23 |