MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-25 for COOK AIRWAY EXCHANGE CATHETER N/A C-CAE-19.0-83 manufactured by Cook Inc.
[139711650]
Blank fields on this form indicate the information is unknown, or unavailable. Phone: (b)(6). Occupation: unknown. Pma/510(k) #: exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[139711652]
It was reported that while using a cook airway exchange catheter during a tube exchange, plastic parts were found inside the catheter during flushing. The product was not inspected prior to use, as it is a daily use product. Additional information has been requested regarding event details and patient demographics, but is not available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00753 |
| MDR Report Key | 8448382 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-25 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-31 |
| Device Manufacturer Date | 2017-05-17 |
| Date Added to Maude | 2019-03-25 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK AIRWAY EXCHANGE CATHETER |
| Generic Name | LRC CHANGER, TUBE, ENDOTRACHEAL |
| Product Code | LRC |
| Date Received | 2019-03-25 |
| Model Number | N/A |
| Catalog Number | C-CAE-19.0-83 |
| Lot Number | 7920952 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-25 |