Brand Name | WARMTOUCH |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
CELSIUS MEDICAL S.L |
ctra. de ajalvir, km 5,200 |
ajalvir 28864 |
ES 28864 |
|
Manufacturer (Section G) |
CELSIUS MEDICAL S.L |
ctra. de ajalvir, km 5,200 |
|
ajalvir 28864 |
ES
28864
|
|
Manufacturer Contact |
avi
kluger
|
5920 longbow drive |
boulder, CO 80301
|
3035306582
|
|
MDR Report Key | 9934404 |
MDR Text Key | 187380447 |
Report Number | 2936999-2020-00259 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
UDI-Device Identifier | 10884521190672 |
UDI-Public | 10884521190672 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123083 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/08/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 5016000-RC |
Device Catalogue Number | 5016000-RC |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/18/2020 |
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 |
|
|