Brand Name | UP & UP BR HDS SMSNC PREM ANTIPLQ 2PK |
Type of Device | TOOTHBRUSH, POWERED |
Manufacturer (Section D) |
RANIR LLC |
4701 east paris ave se |
grand rapids MI 49512 5353 |
|
Manufacturer (Section G) |
RANIR LLC |
4701 east paris ave. se |
|
grand rapids MI 49512 5353 |
|
Manufacturer Contact |
|
MDR Report Key | 13517251 |
MDR Text Key | 288180038 |
Report Number | 1825660-2022-01048 |
Device Sequence Number | 1 |
Product Code |
JEQ
|
UDI-Device Identifier | 1373381567 |
UDI-Public | 1373381567 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/11/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/11/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | BR HDS SMSNC PREM ANTIPLQ 2PK |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 01/13/2022 |
Date Manufacturer Received | 01/13/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |