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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXYCODONE URINE TEST

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OXYCODONE URINE TEST Back to Search Results
Device Problems False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2015
Event Type  Malfunction  
Event Description

(b)(4) is selling falsely advertised oxycodone urine tests. These are not oxycodone tests, but rather general opiate tests. It will test positive if any opiate is in your system. (b)(4) will not answer any of my messages, emails or letters regarding this issue and provided me with an incorrect address to return this product, which was returned to me twice. Lab tests showed no oxycodone in my urine, while (b)(4) tests showed oxycodone being in my system (after 2+ months after taking an oxycodone tablet). Which is impossible.

 
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Brand NameOXYCODONE URINE TEST
Type of DeviceOXYCODONE URINE TEST
MDR Report Key5124330
MDR Text Key27476966
Report NumberMW5056784
Device Sequence Number1
Product Code DJG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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