MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-08 for ORA QUICK HIV-1/2 OMT RAPID ANTIBODY TEST PRIVATE AT HOME SALIVA CHECK NO BLOOD manufactured by Unk.
[127355442]
Problem 1: i am writing to report an (b)(6) seller, that currently selling fake ora quick hiv-1/2 test from (b)(6) united states website. I bought an ora quick hiv-1/ test from this seller on (b)(6) united states website, (b)(6) item number: (b)(4), (b)(6). Firstly, i opened the box and found out all written in (b)(4), and instructions inside 'written named as aware hiv 1/2 omt test' and then used it to swab around my mouth, and test result showed as defective. Would fda officer investigate this issue? Problem 2: in addition, this (b)(6) seller is also currently selling another prescription medical devices as below: (not fda approved) hiv1/2 (aids) and syphilis (tp) combo test one step 2in1 check sti std screen kit (b)(6) item number: (b)(4). (b)(6). This ebay seller completely ignores us law, and selling (non-fda approved) prescription medical devices to public, put people's health in high risk, would fda officer resolve this health matter? (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081169 |
| MDR Report Key | 8055028 |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-11-04 |
| Date Added to Maude | 2018-11-09 |
| 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 | ORA QUICK HIV-1/2 OMT RAPID ANTIBODY TEST PRIVATE AT HOME SALIVA CHECK NO BLOOD |
| Generic Name | ORA QUICK HIV-1/2 OMT RAPID ANTIBODY TEST PRIVATE AT HOME SALIVA CHECK NO BLOOD |
| Product Code | MTL |
| Date Received | 2018-11-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit | 2018-11-08 |