MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-10 for UNK manufactured by .
[683335]
In 2007, i was asked to give a breathalyzer sample at the criminal process center. I observed condensation inside the clear tube leading from the mouth piece into the test device. This condensation obviously collected in the tube from previous test subjects. I am required by law to give a sample of my breath or lose my driving privileges for a year. I could not give a sample in gear of accidentally inhaling any airborne or foreign germs. This is not a proper sanitary practice and i have been getting the run around from local sources. You are, i understand, responsible for insuring the devices i have described earlier are being kept to fda standards. Please have one of your representatives call me as soon as possible or call my legal representative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003708 |
| MDR Report Key | 910392 |
| Date Received | 2007-09-10 |
| Date of Report | 2007-09-07 |
| Date of Event | 2007-07-01 |
| Date Added to Maude | 2007-09-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BREATHALYZER |
| Product Code | DJZ |
| Date Received | 2007-09-10 |
| Model Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 887508 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2007-09-10 |