Brand Name | NL9000S |
Type of Device | DENTAL HANDPIECE, AIR-POWERED, DENTAL |
Manufacturer (Section D) |
NAKANISHI INC. (NSK) |
700 shimohinata |
kanuma-shi, tochigi-ken, 322-8 6666 |
JA 322-86666 |
|
MDR Report Key | 7441515 |
MDR Text Key | 105874281 |
Report Number | 1032227-2018-00002 |
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 |
04/18/2018 |
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 | 5021262U0 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/18/2018 |
Distributor Facility Aware Date | 03/22/2018 |
Device Age | 10 MO |
Event Location |
Other
|
Date Report to Manufacturer | 04/18/2018 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/18/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|