Brand Name | TI-MAX X |
Type of Device | DENTAL HANDPIECE |
Manufacturer (Section D) |
NAKANISHI INC. |
700 shimohinata |
kanuma, tochigi 322-8 666 |
JA 322-8666 |
|
MDR Report Key | 16018774 |
MDR Text Key | 305873056 |
Report Number | 1422375-2022-00054 |
Device Sequence Number | 1 |
Product Code |
KMW
|
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 |
12/01/2022,12/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | X-SG93 |
Device Catalogue Number | C1007 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/08/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 11/22/2022 |
Device Age | 2 YR |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 12/01/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|