Brand Name | ALLURA XPER FD10 |
Type of Device | SYSTEM, X-RAY, ANGIOGRAPHIC |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
veenpluis 4-6 |
best 5684 PC |
NL 5684 PC |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
veenpluis 4-6 |
|
best 5684 PC |
NL
5684 PC
|
|
Manufacturer Contact |
dusty
leppert
|
222 jacobs st |
cambridge, MA 02141
|
6172455900
|
|
MDR Report Key | 12842746 |
MDR Text Key | 281004856 |
Report Number | 3003768277-2021-10233 |
Device Sequence Number | 1 |
Product Code |
IZI
|
UDI-Device Identifier | 00884838059191 |
UDI-Public | 00884838059191 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K041949 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Remedial Action |
Notification |
Type of Report
| Initial |
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 | ALLURA XPER FD10 |
Device Catalogue Number | 722003 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/04/2021
|
Initial Date FDA Received | 11/19/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/29/2007 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|