MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-23 for COMFORTRON II NI manufactured by *.
[21251455]
Dentist had been using a 3m dental anesthesia device on pts who stress over getting an injection. Dentist was having difficulty obtaining the leads for the 3m device, so they decided to go with the comfortron ii electronic dental anesthesia (eda) from electrosurgical resources inc. Dentist claims the device was not effective on pts. When used on pts they still felt pain. The manual provided by the company was a xerox copy. Dentist is trying to get money back from the comfortron.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003418 |
| MDR Report Key | 435595 |
| Date Received | 2002-10-23 |
| Date of Report | 2002-10-23 |
| Date Added to Maude | 2003-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORTRON II |
| Generic Name | ELECTRONIC DENTAL ANESTHESIA DEVICE |
| Product Code | LWM |
| Date Received | 2002-10-23 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NA |
| ID Number | NI |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 424510 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-10-23 |