Brand Name | ARROW 8FR 30 CC IAB FIBEROPTIX |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
TELEFLEX INCORPORATED |
po box 12600 |
durham NC 27709 |
|
MDR Report Key | 12487565 |
MDR Text Key | 271918741 |
Report Number | 12487565 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
09/02/2021,06/29/2021 |
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 |
No Information
|
Device Lot Number | 18F19M0015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/02/2021 |
Date Report to Manufacturer | 09/17/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/17/2021 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 24820 DA |
|
|