Brand Name | BAIR HUGGER |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
3M COMPANY |
3m center, 2510 conway ave. |
bldg. 275-5w-06 |
saint paul MN 55144 |
|
MDR Report Key | 8101255 |
MDR Text Key | 128257560 |
Report Number | 8101255 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
11/16/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/26/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 775 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/16/2018 |
Date Report to Manufacturer | 11/26/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 27740 DA |
|
|