Brand Name | IAB: 8 FR - 40 CC FOS |
Type of Device | INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM |
Manufacturer (Section D) |
ARROW INTL., INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTL., INC. |
9 plymouth st. |
|
everett MA 02149 |
|
Manufacturer Contact |
kathryn
myers, regulatory associa
|
2400 bernville rd |
reading, PA 19605
|
6103780131
|
|
MDR Report Key | 3885934 |
MDR Text Key | 4651899 |
Report Number | 1219856-2014-00107 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K021462 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/27/2014 |
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 | IAB-05840-LWS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/27/2014 |
Initial Date FDA Received | 06/03/2014 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Other;
|
Patient Age | 55 YR |
|
|