MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-07-02 for manufactured by .
[16657605]
The dental handpiece was not returned for eval. We could not determine the cause of the problem. The instruction state lubricate before each use to keep it running properly. Until we could get the handpiece back for eval, we cannot determine what caused the problem. We will monitor for other similar complaints and make any corrective action as we see necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611253-2008-00002 |
| MDR Report Key | 1250923 |
| Report Source | 01,05 |
| Date Received | 2008-07-02 |
| Date Mfgr Received | 2008-07-02 |
| Date Added to Maude | 2008-12-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, TOCHIGI-KEN 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal | 322-8666 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | EKA |
| Date Received | 2008-07-02 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1031040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-02 |