Brand Name | PREVI COLOR GRAM INSTRUMENT |
Type of Device | PREVI® COLOR GRAM INSTRUMENT |
Manufacturer (Section D) |
BIOMERIEUX SA |
chemin de l orme |
marcy l etoile, rhone 69280, |
FR |
|
MDR Report Key | 9131177 |
MDR Text Key | 219774486 |
Report Number | 8020790-2019-00056 |
Device Sequence Number | 1 |
Product Code |
KPA
|
UDI-Device Identifier | 03573026415310 |
UDI-Public | 03573026415310 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
07/08/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/27/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 414292 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 06/11/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|