FDA Adverse Event
Injury
Summary report: N
CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM
MDR report key: 7533988
·
Received May 21, 2018
Report
- Report Number
- MW5077373
- Event Type
- Injury
- Date Received
- May 21, 2018
- Date of Event
- February 21, 2018
- Report Date
- May 20, 2018
- Manufacturer
- AMERITOX
- Product Code
- DJC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MS, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WAS AT A ROUTINE PHYSICIAN VISIT WHEN ASK IF I WOULD TAKE THE DRUG SCREEN BECAUSE OF A NEW REGULATION BEING IMPLEMENTED. I DID. THEN I WAS TOLD THAT I FAILED THE TEST FOR METHAMPHETAMINE AND WAS DENIED PRESCRIPTIONS FOR XANAX, ALTHOUGH I WAS ADVISED NOT TO ABRUPTLY STOP TAKING THEM, WAS NOT REFERRED TO ANOTHER PHYSICIAN. I TOLD THEM THAT THE TEST WAS WRONG, AS I HAD NOTHING IN MY SYSTEM OTHER THAN PRESCRIBED MEDICATIONS BUT WAS TOLD THAT I COULD NOT RETAKE THE TEST AND NOTHING COULD BE DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371659 | CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM | CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM | DJC | AMERITOX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |