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 2020-03-27 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FIC manufactured by William Cook Europe.
[185666479]
Manufacturer ref# (b)(4). Similar to device under pma/510(k) k161813. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[185666480]
Description of event according to initial reporter: they wanted to place a double lumen tube with the frova and after procedure they found that blue parts of the frova remained in the patient but doctor could retrieve all. At the end of a rigid bronchoscopy re-intubation with frova. Afterwards a double lumen tube was placed over the frova. At control after final positioning of the patient, 3 small rubber parts were observed at the transition from double lumen tube to left bronchus. Easy removal of the femoral body by suction. Patient outcome: no injury to patient. A section of the device did not remain inside the patient? S body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2020-00368 |
| MDR Report Key | 9887457 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2020-01-16 |
| Date Added to Maude | 2020-03-27 |
| 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. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FROVA INTUBATING INTRODUCER |
| Generic Name | BTR TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-27 |
| Catalog Number | C-CAE-14.0-70-FIC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |