MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-01-04 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FIC manufactured by William Cook Europe.
[132921715]
(b)(4). Name and address for importer site: (b)(4). Similar to device under pma/510(k) e597079 (k161813). Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[132921716]
Description of event according to initial reporter: patient was admitted 2 days later with severe sore throat. The diagnosis of the sore throat was surgical emphysema most likely due to abrasion of the trachea from the intubation due to bougie. He recovered subsequently. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2019-00013 |
| MDR Report Key | 8216517 |
| Report Source | OTHER |
| Date Received | 2019-01-04 |
| Date of Report | 2019-04-03 |
| Date of Event | 2018-10-12 |
| Date Facility Aware | 2018-12-11 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-04 |
| 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 | 2019-01-04 |
| 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 | 2019-01-04 |