MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for UNKNOWN manufactured by William Cook Europe.
[186732663]
It is alleged that "[pt] received a cook gunther tulip 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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005580113-2020-00315 |
| MDR Report Key | 9897393 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Facility Aware | 2020-03-12 |
| Report Date | 2020-03-30 |
| Date Reported to FDA | 2020-03-30 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| 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 | 2020-03-30 |