MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-20 for CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET UNK manufactured by Cook, Inc..
[1730458]
Information was provided to cook by an area rep that on (b)(6) 2010, the rep was to attend a dolphin balloon assisted tracheostomy (bat) case in the operating room at (b)(6) medical center. Upon arrival, the attending physician informed the rep that in the last case when the facility used a cook tracheostomy device, the pt died on the table. It was explained that the physician did not feel it was the product's doing, but a result of the procedure. No information was provided regarding pt (sex, weight, age, etc). The physician was not certain as to which tracheostomy product of cook's was used. Additional information was provided on (b)(6) 2010 that the expired pt was not the reporting physician's pt.
Patient Sequence No: 1, Text Type: D, B5
[8970778]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2011-00047 |
| MDR Report Key | 1972475 |
| Report Source | 07 |
| Date Received | 2011-01-20 |
| Date of Report | 2010-12-22 |
| Report Date | 2010-12-22 |
| Date Mfgr Received | 2010-12-28 |
| Date Added to Maude | 2011-02-01 |
| 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 | RITA HARDEN, MGR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET |
| Generic Name | KCG DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2011-01-20 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | * BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-01-20 |