Brand Name | 3M BAIR HUGGER WARMING UNIT 775 |
Type of Device | HYPER/HYPOTHERMA SYSTEM, PRODUCT CODE: DWJ |
Manufacturer (Section D) |
3M HEALTH CARE |
2510 conway ave |
st. paul MN 55144 |
|
Manufacturer (Section G) |
3M COMPANY EDEN PRAIRIE |
10351 west 70th street |
|
eden prairie MN 55344 |
|
Manufacturer Contact |
dianne
gibbs
|
3m center, building 275-5w-06 |
2510 conway ave |
st. paul, MN 55144
|
6517379117
|
|
MDR Report Key | 11611922 |
MDR Text Key | 244917958 |
Report Number | 2110898-2021-00018 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K060865 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/04/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 775 |
Device Catalogue Number | 77507 |
Device Lot Number | 125271 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/05/2021 |
Initial Date FDA Received | 04/04/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/26/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |