MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-28 for OXYCODONE URINE TEST manufactured by .
[27476966]
(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
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056784 |
| MDR Report Key | 5124330 |
| Date Received | 2015-09-28 |
| Date of Report | 2015-09-28 |
| Date of Event | 2015-03-10 |
| Date Added to Maude | 2015-10-02 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OXYCODONE URINE TEST |
| Generic Name | OXYCODONE URINE TEST |
| Product Code | DJG |
| Date Received | 2015-09-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-28 |