Brand Name | IMPRESS |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 west merit pkwy. |
south jordan UT 84095 |
|
MDR Report Key | 6089678 |
MDR Text Key | 59513332 |
Report Number | 6089678 |
Device Sequence Number | 1 |
Product Code |
DQO
|
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 |
09/20/2016,09/28/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 04/30/2019 |
Device Model Number | 56538KA2 |
Device Catalogue Number | 56538KA2 |
Device Lot Number | E955751 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/20/2016 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/20/2016 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/09/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 71 YR |
|
|