Brand Name | EASY FLEX ULTRA + |
Type of Device | MANUAL TOOTHBRUSH |
Manufacturer (Section D) |
RANIR LLC |
4701 east paris se |
grand rapids MI 49512 535 |
|
Manufacturer (Section G) |
RANIR LLC |
4701 east paris se |
|
grand rapids MI 49512 535 |
|
Manufacturer Contact |
elsa
baker
|
4701 east paris ave se |
grand rapids, MI 49512-5353
|
6166988880
|
|
MDR Report Key | 4908023 |
MDR Text Key | 6027413 |
Report Number | 1825660-2015-00076 |
Device Sequence Number | 1 |
Product Code |
EFW
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Device Unattended
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
07/12/2015 |
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 |
Other
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/12/2015
|
Initial Date FDA Received | 07/13/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|