Brand Name | HOT PACK, MEDIUM, 6X6.5IN |
Type of Device | PACK, HOT OR COLD, DISPOSABLE |
Manufacturer (Section D) |
MO016 MO-MOBERLY |
808 w highway 24 |
moberly MO 65270 |
|
Manufacturer (Section G) |
MO016 MO-MOBERLY |
808 w highway 24 |
|
moberly MO 65270 |
|
Manufacturer Contact |
patricia
tucker
|
3651 birchwood dr |
waukegan, IL 60085
|
8478874151
|
|
MDR Report Key | 14322521 |
MDR Text Key | 291752469 |
Report Number | 1423537-2022-00764 |
Device Sequence Number | 1 |
Product Code |
IMD
|
UDI-Device Identifier | 10885380167188 |
UDI-Public | 10885380167188 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/06/2022 |
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 | 11450-040B |
Device Catalogue Number | 11450-040B |
Device Lot Number | V2B266 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
04/13/2022
|
Initial Date FDA Received | 05/07/2022 |
Date Device Manufactured | 02/24/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|