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 2019-02-01 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FIC manufactured by William Cook Europe.
[134699182]
(b)(4). Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[134699183]
Patient was lying in the induction room to be anesthetized. During intubation the material was scraped off the frova by the double lumen tube. When the doctors noticed it the material had to be removed through the bronchoscope. The patient required additional procedure due to this occurrence: the material of frova had to be removed through the bronchoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2019-00143 |
| MDR Report Key | 8295897 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2019-02-01 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-14 |
| Date Facility Aware | 2019-01-14 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-02-01 |
| 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 | 2019-02-01 |
| Catalog Number | C-CAE-14.0-70-FIC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-02-01 |