MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for UNKNOWN manufactured by William Cook Europe.
[188825059]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188825060]
It is alleged that "[pt] received a cook celect filter on (b)(6) 2010. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. " on (b)(6) 2018, per a report from computed tomography (ct);? Findings: 1 ivc filter as described with slight tilt. It is located close to the lowest renal vein on the right side. The distal prongs of the ivc are projecting outside of the lumen of the ivc.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005580113-2020-00311 |
| MDR Report Key | 9889967 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Facility Aware | 2020-03-11 |
| Report Date | 2020-03-27 |
| Date Reported to FDA | 2020-03-27 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Product Code | DTK |
| Date Received | 2020-03-27 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-27 |