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 2019-01-03 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FIC manufactured by William Cook Europe.
[131904364]
(b)(4). Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Similar to device under 510(k): e597079 (k161813). Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[131904365]
During removal of the blue mandril for difficult intubation the frova was used through a selective intubation probe (type carlens), its extremity was propped from frova, despite lubrication of the frova mandril, a very small part detached au vue in light of the fibroscopy. It was removed with the fibroscopy. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2018-01531 |
| MDR Report Key | 8211841 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2019-01-03 |
| Date of Report | 2019-03-04 |
| Date of Event | 2018-11-30 |
| Date Facility Aware | 2018-12-07 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-01-03 |
| 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 | 2019-01-03 |
| 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 | 2019-01-03 |