CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM manufactured by Ameritox.

Event Text Entries

[108990443] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077373
MDR Report Key7533988
Date Received2018-05-21
Date of Report2018-05-20
Date of Event2018-02-21
Date Added to Maude2018-05-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM
Generic NameCHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM
Product CodeDJC
Date Received2018-05-21
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAMERITOX


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2018-05-21

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