Brand Name | MIGHTY BLISS |
Type of Device | HEATING PAD |
Manufacturer (Section D) |
XI AN BELLAVIE AND SUNBRIGHT GROUP CO.,LTD. |
4-1101, taihua jinmao |
intl plaza, n16th s fenghui rd |
xi'an, shaanxi |
CH |
|
MDR Report Key | 16616855 |
MDR Text Key | 312006693 |
Report Number | 3016774562-2023-00730 |
Device Sequence Number | 1 |
Product Code |
IRT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Model Number | NA-H1121B |
Device Lot Number | 210905 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/26/2023 |
Distributor Facility Aware Date | 02/24/2023 |
Device Age | 2 YR |
Date Report to Manufacturer | 02/28/2023 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/26/2023 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/25/2024
|
Patient Sequence Number | 1 |
Patient Sex | Male |
|
|