Brand Name | ALLURA FC |
Type of Device | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
veenpluis 6 |
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NL 5684 PC |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
veenpluis 6 |
|
best 5684 PC |
NL
5684 PC
|
|
Manufacturer Contact |
derrick
massuri
|
3000 minuteman rd |
andover, MA 01810
|
6172455900
|
|
MDR Report Key | 18847401 |
MDR Text Key | 337676550 |
Report Number | 3010685285-2024-00001 |
Device Sequence Number | 1 |
Product Code |
JAA
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K022899 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
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 FC |
Device Catalogue Number | 723003 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/11/2024 |
Initial Date FDA Received | 03/06/2024 |
Supplement Dates Manufacturer Received | 03/11/2024
|
Supplement Dates FDA Received | 03/13/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/13/2015 |
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 |
|
|