MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-02 for ENDO-EXPRESS TEP-E4R 5500-00 manufactured by Nakanishi, Inc. (nsk).
[994557]
The doctor used a dental handpiece on the pt and the handpiece overheated. No one was injured. Ref mfr# 9611253-2008-00001, imp# (b)(4), mw5007345, mw5007346.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433629-2008-00002 |
| MDR Report Key | 1250879 |
| Date Received | 2008-07-02 |
| Date of Report | 2008-07-02 |
| Date of Event | 2007-01-30 |
| Report Date | 2008-07-02 |
| Date Reported to FDA | 2008-07-02 |
| Date Reported to Mfgr | 2008-07-02 |
| Date Added to Maude | 2008-12-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO-EXPRESS |
| Generic Name | DENTAL HANDPIECE |
| Product Code | EKA |
| Date Received | 2008-07-02 |
| Model Number | TEP-E4R |
| Catalog Number | 5500-00 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1031040 |
| Manufacturer | NAKANISHI, INC. (NSK) |
| Manufacturer Address | * KANUMA-SHI, TOCHIGI-KEN * JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-02 |