Brand Name | ULTRAVERSE |
Type of Device | CATHETER, DILATION BALLOON |
Manufacturer (Section D) |
BARD PERIPHERAL VASCULAR |
1625 west 3rd street |
tempe AZ 85281 |
|
MDR Report Key | 5317687 |
MDR Text Key | 34087200 |
Report Number | 5317687 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/16/2015,12/07/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | U357574 |
Device Lot Number | 50119011 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/16/2015 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/16/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/22/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 50 YR |
Patient Weight | 84 |
|
|