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 2018-06-12 for ARNDT ENDOBRONCHIAL BLOCKER SET UNKNOWN manufactured by Cook Inc.
[111022172]
Based on device name physician reported. (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
[111022173]
A physician reported to a cook representative during a conference he had received a batch of arndt endobronchial blocker balloons that collapsed after less than 12 hours in use. As reported, the doctor stated this defect occurred three times. Medwatch 1820334-2018-01677 is being reported as device malfunctions with no patient harm. Medwatch 1820334-2018-01676 is reporting a patient death. To date, additional information is unable to be provided by the reporting physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01678 |
| MDR Report Key | 7591032 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-12 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-06-12 |
| 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 | 2018-06-12 |
| 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 | 2018-06-12 |