Brand Name | ACCUVU |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
ANGIODYNAMICS, INC. |
603 queensbury ave. |
queensbury NY 12804 |
|
MDR Report Key | 17555468 |
MDR Text Key | 321233509 |
Report Number | 17555468 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/09/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 13709803 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/09/2023 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/16/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/16/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Sex | Female |
|
|