MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-02-13 for ONSITE ALCOHOL 47464 manufactured by Ansys Tech Inc..
[242508]
A worker was driving a fork lift truck too fast, turned and a pallet fell off and hit an individual. The worker admitted to drinking 8 beers at 1pm. At 6:30pm the worker was given an alcohol test with the suspect device and it was negative. The management could smell alcohol on the worker's breath. The worker was given a breathalyzer and it was 0. 27. The suspect device was checked again at 10 minutes and the result was now positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2002-00048 |
| MDR Report Key | 377579 |
| Report Source | 04 |
| Date Received | 2002-02-13 |
| Date of Report | 2002-01-22 |
| Date of Event | 2002-01-17 |
| Date Mfgr Received | 2002-01-22 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2002-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEBARA REEK |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175763857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1823260-01/24/02-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONSITE ALCOHOL |
| Generic Name | ALCOHOL DETECTION DEVICE |
| Product Code | DML |
| Date Received | 2002-02-13 |
| Model Number | NA |
| Catalog Number | 47464 |
| Lot Number | 0110704 |
| ID Number | NA |
| Device Expiration Date | 2002-07-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 366645 |
| Manufacturer | ANSYS TECH INC. |
| Manufacturer Address | 25200 COMMERCE CTR DR LAKE FOREST CA * US |
| Baseline Brand Name | ONSITE ALCOHOL |
| Baseline Generic Name | ONSITE ALCOHOL |
| Baseline Model No | NA |
| Baseline Catalog No | 47464 |
| Baseline ID | NA |
| Baseline Device Family | ALCOHOL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K963197 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-02-13 |