Brand Name | TRIAGE PROFILER SOB PANEL |
Type of Device | TRIAGE PROFILER SOB PANEL |
Manufacturer (Section D) |
QUIDEL CARDIOVASCULAR INC. |
9975 summers ridge road |
san diego CA 92121 |
|
Manufacturer Contact |
chelsea
lindgren
|
9975 summers ridge road |
san diego, CA 92121
|
8583020294
|
|
MDR Report Key | 15777612 |
MDR Text Key | 307562390 |
Report Number | 3013982035-2022-00016 |
Device Sequence Number | 1 |
Product Code |
GHH
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K080269 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/10/2022 |
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 Expiration Date | 03/19/2023 |
Device Model Number | 97300EU |
Device Lot Number | T13324N |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/14/2022
|
Initial Date FDA Received | 11/11/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/15/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | TRIAGE METERPRO PN: 55071, SN: (B)(4). |
Patient Sex | Female |