Brand Name | HENRY SCHEIN |
Type of Device | MASTER PUSH BUTTON HANDPIECE |
Manufacturer (Section D) |
NAKANISHI INC. |
700 shimohinata |
kanuma-shi, tochigi-ken 322-8 666 |
JA 322-8666 |
|
MDR Report Key | 5685393 |
MDR Text Key | 46101415 |
Report Number | 2411236-2016-00004 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
05/27/2016,05/02/2016 |
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 Operator |
Dentist
|
Device Catalogue Number | 100-8267 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/24/2016 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/27/2016 |
Distributor Facility Aware Date | 05/02/2016 |
Event Location |
Other
|
Date Report to Manufacturer | 05/27/2016 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/27/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 24 YR |
|
|