Brand Name | VIDAS® BRAHAMS PROCALCITONIN |
Type of Device | VIDAS® BRAHAMS PCT |
Manufacturer (Section D) |
BIOMERIEUX SA |
chemin de l orme |
marcy l etoile, rhone 69280, |
FR
|
|
Manufacturer (Section G) |
BIOMERIEUX SA |
chemin de l orme |
|
marcy l etoile, rhone 69280, |
FR
|
|
Manufacturer Contact |
debra
broyles
|
595 anglum road |
hazelwood, MO 63042
|
3145068201
|
|
MDR Report Key | 8669246 |
MDR Text Key | 213479409 |
Report Number | 8020790-2019-00031 |
Device Sequence Number | 1 |
Product Code |
PRI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071146 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/09/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 06/04/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 11/27/2019 |
Device Catalogue Number | 30450-01 |
Device Lot Number | 1006974220 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/14/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/05/2018 |
Is the Device Single Use? |
No Answer Provided
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|