MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-02 for PROPHY ANGLE SCREW TYPE * 100-0832 manufactured by Nakanishi Inc..
[16257178]
While polishing the pt's teeth, the prophy angle burned the inside of the pt's mouth and left an ulcer. No immediate medical attention was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2006-19268 |
| MDR Report Key | 807189 |
| Date Received | 2007-01-02 |
| Date of Report | 2006-12-06 |
| Date of Event | 2006-12-05 |
| Date Facility Aware | 2006-12-06 |
| Report Date | 2007-01-02 |
| Date Reported to FDA | 2007-01-02 |
| Date Reported to Mfgr | 2007-01-02 |
| Date Added to Maude | 2007-01-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | PROPHY ANGLE SCREW TYPE |
| Generic Name | DENTAL |
| Product Code | KBW |
| Date Received | 2007-01-02 |
| Model Number | * |
| Catalog Number | 100-0832 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 794693 |
| Manufacturer | NAKANISHI INC. |
| Manufacturer Address | * TOCHIGI-KEN * JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-02 |