AMERITOX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-22 for AMERITOX manufactured by .

Event Text Entries

[2040549] I was a pt who was using my medicine as prescribed. I never used more or less. One day, i was told to take a ameritox test and i did willingly and i did not think anything of it as i was not taking anything not prescribed or taking too much. My first test came back as too low and the next one came back that i was taking double the amount, which i was not. I was then taken off all pain meds and given 30 methadone to last till all off. I had been taking 120 oxycodone and 120 methadone. I was functioning with my disability and going to school again then this happened and i was in a car accident and now i am only given ibuprofen when the amount of proven damage done to me from the accident is extensive and i was already in a great amount of pain. The ameritox does not work right. I told the truth about what i took and it gave the wrong results and because of that little test my life is destroyed. I can't even get up and walk some days. Dates of use: (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5021511
MDR Report Key	2182325
Date Received	2011-07-22
Date of Report	2011-07-22
Date of Event	2011-01-01
Date Added to Maude	2011-08-04
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
Reporter Occupation	PATIENT
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

Device Details

Brand Name	AMERITOX
Generic Name	TEST
Product Code	DJG
Date Received	2011-07-22
Device Availability	N
Device Sequence No	1
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-07-22