MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-02-08 for STND TRACH CARE TRAY W/PROXDE 47885 manufactured by Tyco Healthcare/kendall.
[18822364]
It was reported to mfr that a customer had a problem with a trach brush. The customer stated, that a patient had a trach brush break and fall down his trach. He was able to retrieve it and no medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
[18999469]
Per the customer, a sample will not be returned for investigation. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2007-00009 |
| MDR Report Key | 819233 |
| Report Source | 06 |
| Date Received | 2007-02-08 |
| Date of Report | 2007-01-25 |
| Date Reported to Mfgr | 2007-01-25 |
| Date Mfgr Received | 2007-01-25 |
| Date Added to Maude | 2007-02-22 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| 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 | STND TRACH CARE TRAY W/PROXDE |
| Generic Name | TRACH BRUSH |
| Product Code | LRQ |
| Date Received | 2007-02-08 |
| Model Number | 47885 |
| Catalog Number | 47885 |
| 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 | 806722 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Baseline Brand Name | STANDARD TRACH CARE TRAY |
| Baseline Generic Name | TRACH CARE TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 47885 |
| 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 | 2007-02-08 |