MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-19 for ACCUTRON * manufactured by Accutron.
[252379]
An incident occurred in the office with a n2o-o2 unit that was recently installed. The pipes were crossed in the walls. Dentist was giving patients 100% n2o when they thought they were giving them 100% o2. The problem was compounded by the use of a flavored mask. The scent interfered with the characteristic odor of n2o. Dentist could not smell the odor of n2o. They could only smell the scent from the flavored mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026863 |
| MDR Report Key | 430489 |
| Date Received | 2002-12-02 |
| Date of Report | 2002-11-19 |
| Date of Event | 2002-10-01 |
| Date Added to Maude | 2002-12-04 |
| 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 | ACCUTRON |
| Generic Name | NASAL HOOD WITH SCENTS |
| Product Code | KHA |
| Date Received | 2002-11-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 419461 |
| Manufacturer | ACCUTRON |
| Manufacturer Address | 1733 WEST PARKSIDE LANE PHOENEX AZ 85027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-02 |