MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-09-18 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FII manufactured by William Cook Europe.
[120520290]
(b)(4). Name and address for importer site: (b)(4). Ec method code: (b)(4) - type of investigation not yet determined. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[120520291]
Description of event according to initial reporter: frova broke during procedure. Part of the broken frova went into patient's lung. Additional information received 03sep2018: frova broke during procedure. Approximately 10cm from frova's distal tip broken and falls into the bronchus. Patient outcome: managed to retrieve the broken part from bronchus, no additional procedures required
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2018-01100 |
| MDR Report Key | 7884221 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-09-18 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-08-31 |
| Date Facility Aware | 2018-09-03 |
| Date Mfgr Received | 2018-10-08 |
| Date Added to Maude | 2018-09-18 |
| 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 | 2018-09-18 |
| Returned To Mfg | 2018-09-07 |
| Catalog Number | C-CAE-14.0-70-FII |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Life Threatening; 2. Required No Informationntervention | 2018-09-18 |