MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-10-02 for TRACHEOSTOMY CARE TRAY * 47800 manufactured by Kendall.
[16359735]
According to rptr, pt was using the trach brush to clean his trach. While he was doing so, the brush portion of the brush broke off and migrated down pt's throat and lodged in his right lung. Later that same day, he had to have the brush removed. As the brush traveled down his throat, the fragment tore a portion of his throat. A balloon device was placed in pt's throat to protrect and cover the torn portion of his trachea. Atty for this pt stated, "while the front package of your tracheostomy care tray states that the inner cannula should be removed prior to cleaning, we believe that it is certainly foreseeable for someone to attempt to clear the inner cannula without removing the inner cannula and going through all of the procedural steps for cleaning. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-1998-00007 |
| MDR Report Key | 190433 |
| Report Source | 07 |
| Date Received | 1998-10-02 |
| Date Mfgr Received | 1998-09-03 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1998-10-07 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACHEOSTOMY CARE TRAY |
| Generic Name | TRACH CARE TRAY |
| Product Code | LRQ |
| Date Received | 1998-10-02 |
| Model Number | * |
| Catalog Number | 47800 |
| Lot Number | CD0401KG |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 185058 |
| Manufacturer | KENDALL |
| Manufacturer Address | * 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 | 1. Other | 1998-10-02 |