Brand Name | ORAL-B PRECISION CLEAN BRUSHHEADS |
Type of Device | TOOTHBRUSH, POWERED - JEQ |
Manufacturer (Section D) |
BRAUN GMBH WERK MARKTHEIDENFELD |
40 baumhofstrasse |
marktheidenfeld D-978 28 |
GM D-97828 |
|
Manufacturer (Section G) |
BRAUN GMBH WERK MARKTHEIDENFELD |
40 baumhofstrasse |
|
marktheidenfeld D-978 28 |
GM
D-97828
|
|
Manufacturer Contact |
mgr.
affairs, oral care-see co
|
mason business center
8700 ma |
son-montgomery rd |
mason 45040
|
|
MDR Report Key | 16962224 |
MDR Text Key | 315567480 |
Report Number | 3000302531-2023-00209 |
Device Sequence Number | 1 |
Product Code |
JEQ
|
Combination Product (y/n) | Y |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/18/2023 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/19/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A |
Patient Sex | Female |