Brand Name | NOVAPLUS INFANT HEEL WARMER SQUEEZE |
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 drive |
waukegan, IL 60085
|
8478874151
|
|
MDR Report Key | 17965776 |
MDR Text Key | 326050874 |
Report Number | 1423537-2023-00998 |
Device Sequence Number | 1 |
Product Code |
IMD
|
UDI-Device Identifier | 10885380057588 |
UDI-Public | 10885380057588 |
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 |
10/19/2023 |
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 | V11460-010 |
Device Catalogue Number | V11460-010 |
Device Lot Number | V2P199 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/22/2023
|
Initial Date FDA Received | 10/19/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |