MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-02-11 for NSK TI-MAX X450YL P1085 manufactured by Nakanishi Inc..
[188811742]
Nakanishi did not receive any information about the patient, but is scheduled to visit the dentist to obtain the information. This event occurred in (b)(6), but similar products are marketed in the us under k112024.
Patient Sequence No: 1, Text Type: N, H10
[188811803]
On january 20, 2020, nakanishi received a phone call from a dealer about an injury caused by an nsk handpiece. The information nakanishi obtained from the communication is as follows: the event occurred on (b)(6) 2020. A dentist was extracting the patient's #8 tooth using the ti-max x450yl handpiece (serial no. (b)(4)). During the procedure, the dentist found bleeding from an injury on the mucosa of the patient's cheek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2020-00003 |
| MDR Report Key | 9691406 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-07-24 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KENNETH BLOCK |
| Manufacturer Street | 800 E CAMPBELL RD. SUITE 202 |
| Manufacturer City | RICHARDSON, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 4809554 |
| Manufacturer G1 | NAKANISHI INC. |
| Manufacturer Street | 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, TOCHIGI-KEN 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, AIR-POWERED, DENTAL |
| Product Code | EFB |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-01-21 |
| Model Number | TI-MAX X450YL |
| Catalog Number | P1085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAKANISHI INC. |
| Manufacturer Address | 700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-11 |