MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-21 for TRIAGE PLUS TCA DRUG TEST manufactured by Biosite Diagnostics, Inc..
[14919]
Pt came in to the er complaining of a headache. He was sluggish and couldn't remember previous events. Rptr ran the appropriate tests and did a drug screen which was positive. Rptr sent the pt home. The same day the pt went to another facility where the drug screen was negative twice. Subsequently, it was determined that the pt had a brain tumor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006307 |
| MDR Report Key | 22636 |
| Date Received | 1995-06-21 |
| Date of Report | 1995-06-16 |
| Date of Event | 1995-06-13 |
| Date Added to Maude | 1995-06-21 |
| 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 |
| 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 | TRIAGE PLUS TCA DRUG TEST |
| Generic Name | DRUG TEST |
| Product Code | MGX |
| Date Received | 1995-06-21 |
| Lot Number | W6022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22826 |
| Manufacturer | BIOSITE DIAGNOSTICS, INC. |
| Manufacturer Address | SAN DIEGO CA 921211208 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-06-21 |