Brand Name | BLANKETROL |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
CINCINNATI SUB- ZERO PRODUCTS, LLC |
12011 mosteller rd. |
cincinnati OH 45241 |
|
MDR Report Key | 6212377 |
MDR Text Key | 63504261 |
Report Number | 6212377 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/22/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | 874 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/22/2016 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/22/2016 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/29/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Weight | 13 |
|
|