MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-17 for NSK Z95L C1034 manufactured by Nakanishi Inc..
[188811348]
Nakanishi did not receive the patient's age or weight, but is scheduled to visit the dentist to obtain the information.
Patient Sequence No: 1, Text Type: N, H10
[188811349]
On december 25, 2019, nakanishi received a phone call from a dealer about an nsk handpiece overheating. The information nakanishi obtained from the communication is as follows: the event occurred on (b)(6) 2019. A dentist was performing a crown removal on a patient using the z95l handpiece (serial no. (b)(4)). During the procedure, the handpiece overheated and burned the patient.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9611253-2020-00002 |
MDR Report Key | 9599623 |
Report Source | FOREIGN,OTHER |
Date Received | 2020-01-17 |
Date of Report | 2020-02-06 |
Date of Event | 2019-12-23 |
Date Mfgr Received | 2020-01-14 |
Device Manufacturer Date | 2014-09-23 |
Date Added to Maude | 2020-01-17 |
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 75081 |
Manufacturer Country | US |
Manufacturer Postal | 75081 |
Manufacturer Phone | 9724809554 |
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, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL |
Product Code | EGS |
Date Received | 2020-01-17 |
Returned To Mfg | 2019-12-26 |
Model Number | Z95L |
Catalog Number | C1034 |
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, 322-8666 JA 322-8666 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-01-17 |