MAUDE Adverse Event Report: PHAMATECH INC COVID-19 "CORONAVIRUS" IGG / IGM RAPID TEST KIT; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

Event Type  Injury  

Event Description

We are gravely concerned that phamatech is selling unproven and unreliable (b)(6) made serology tests to the general public, which should only be sold through hcp.They are also mislabeling the product.Phamatech is mislabeling the product and selling it to anyone who walks in.Please stop them.Here is the company's website: https://www.Phamatech.Com/index3.Php/.Fda safety report id# (b)(4).

• Brand Name: COVID-19 "CORONAVIRUS" IGG / IGM RAPID TEST KIT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): PHAMATECH INC
• MDR Report Key: 9957564
• MDR Text Key: 187731703
• Report Number: MW5094128
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 04/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 88