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 2019-08-13 for ARNDT ENDOBRONCHIAL BLOCKER SET N/A C-AEBS-5.0-65-SPH-AS manufactured by Cook Inc.
[154438759]
Occupation: unknown. Device available for eval: unknown. Pma/510(k) #: k160542. (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
[154438760]
It was reported an arndt endobronchial blocker set was used during an unknown procedure on an unknown patient. During the procedure, the balloon? Came off? And resulted in a retrieval. Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02006 |
| MDR Report Key | 8890277 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-13 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-02 |
| Report Date | 2019-08-15 |
| Date Reported to FDA | 2019-08-15 |
| Date Mfgr Received | 2019-09-06 |
| Device Manufacturer Date | 2019-05-06 |
| Date Added to Maude | 2019-08-13 |
| 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 | CBI TUBE, TRACHEAL/BRONCHIAL |
| Product Code | CBI |
| Date Received | 2019-08-13 |
| Returned To Mfg | 2019-08-23 |
| Model Number | N/A |
| Catalog Number | C-AEBS-5.0-65-SPH-AS |
| Lot Number | 9716353 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2019-08-13 |