MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-01-28 for FROVA INTUBATING INTRODUCER G23646 C-CAE-14.0-70-FII manufactured by William Cook Europe.
[134178180]
(b)(4). Name and address for importer site: (b)(4). Similar to device under 510(k)/pma: k161813. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[134178181]
Description of event according to initial reporter: product used for difficult intubation. After using the frova stylet, for the positioning of the dual adaptor, a bronchoscopy was performed and a piece of the blue cover of the sheath was also sucked. Additional information received from rep. 03jan2019: i called the chief primary and both were used in thoracic surgery and for sure one of them was used with dlt. Additional information received 14jan2019 from translated document: device used for difficult intubation. After using the frova mandrel to position the double-lumen tube, a bronchoscopy was carried out during which a small piece of the blue sheath covering the tube was aspirated. Patient outcome: no information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2019-00108 |
| MDR Report Key | 8280693 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-01-28 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-12-13 |
| Date Facility Aware | 2019-01-03 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2018-10-09 |
| Date Added to Maude | 2019-01-28 |
| 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 | LRC INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-02-04 |
| Model Number | G23646 |
| Catalog Number | C-CAE-14.0-70-FII |
| Lot Number | E3782903 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-28 |