MAUDE Adverse Event Report: REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 05/21/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, my husband and i went to a free covid testing in (b)(6) at (b)(6).My id for the test was (b)(6).We had the deep single nostril probe/tears came out our eyes.My right nostril was probed.Ever since that test i have nose clog issues and my left nostril runs/stays wet inside.Right nostril feels clogged.Is this a permanent medical condition i will have and what can i do for my nose breathing to be normal again? my husband has no issues after test.No problem with med device, bad nostril side effect after covid test.Covid test left me with one running nostril and one tested clogged.

• Brand Name: REAGENT, CORONAVIRUS SEROLOGICAL
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10205904
• MDR Text Key: 196951150
• Report Number: MW5095250
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 63