Brand Name | LEVEL 1 |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
david
halverson
|
6000 nathan lane north |
prime tower, business bay, p o |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 11008908 |
MDR Text Key | 221452278 |
Report Number | 3012307300-2020-19950 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Reporter Country Code | AE |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | L1-CW-220V |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/23/2021 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/17/2020 |
Initial Date FDA Received | 12/15/2020 |
Supplement Dates Manufacturer Received | 01/29/2021 07/09/2021
|
Supplement Dates FDA Received | 02/27/2021 02/10/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/04/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|