Brand Name | SOLUTION PACK - SP90 |
Type of Device | SOLUTION PACK - SP90 XL |
Manufacturer (Section D) |
RADIOMETER MEDICAL APS |
aakandevej 21 |
broenshoej, 2700 |
DA 2700 |
|
Manufacturer (Section G) |
RADIOMETER MEDICAL APS |
aakandevej 21 |
|
broenshoej, 2700 |
DA
2700
|
|
Manufacturer Contact |
david
kawiecki
|
aakandevej 21 |
broenshoej, 2700
|
DA
2700
|
|
MDR Report Key | 6960656 |
MDR Text Key | 90634311 |
Report Number | 3002807968-2017-00037 |
Device Sequence Number | 1 |
Product Code |
CHL
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K092686 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/05/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/19/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 01/30/2018 |
Device Model Number | 944-457 |
Device Catalogue Number | 944-457 |
Device Lot Number | YR-53 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/20/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/16/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|