Brand Name | UNKNOWN |
Type of Device | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
Manufacturer (Section D) |
WILLIAM COOK EUROPE |
sandet 6 |
bjaeverskov 4632 |
DA 4632 |
|
MDR Report Key | 17234270 |
MDR Text Key | 318170719 |
Report Number | 3005580113-2023-00075 |
Device Sequence Number | 1 |
Product Code |
DTK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/28/2023,06/29/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Distributor Facility Aware Date | 06/09/2023 |
Event Location |
Hospital
|
Date Report to Manufacturer | 06/28/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 06/29/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 51 YR |
Patient Sex | Female |
Patient Weight | 78 KG |
|
|