MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-08 for ARNDT ENDOBRONCHIAL BLOCKER SET UNKNOWN manufactured by Cook Inc.
[110483567]
(b)(4). 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
[110483568]
A physician reported to a cook representative at a booth during a conference he had a batch of arndt endobronchial blocker balloons that collapsed after less than 12 hours in use. As reported, the doctor stated this device issue occurred three times involving three patients. Medwatch 1820334-2018-01678 is being reported as device malfunctions. Medwatch 1820334-2018-01676 is reporting a patient that did not survive. As reported, the physician does not feel this device defect caused or contributed to the patient's fatality. To date, additional information is unable to be provided by the reporting physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01677 |
| MDR Report Key | 7582301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-08 |
| Date of Report | 2018-09-19 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-06-08 |
| 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 | ARNDT ENDOBRONCHIAL BLOCKER SET |
| Generic Name | BWC NEEDLE, EMERGENCY AIRWAY |
| Product Code | BWC |
| Date Received | 2018-06-08 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-06-08 |