MAUDE Adverse Event Report: Q-TIP; APPLICATOR, ABSORBENT TIPPED, STERILE

Device Problem Defective Component (2292)

Patient Problem Pain (1994)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Went to have a rapid covid 19 test done, at (b)(6).When arrived the qtip was big and moist.Having issues my head hurts since then.Dr.(b)(6) is head doctor at this location.And on the results that says nothing about covid-19.It says- "in house rapid sars cov, respiratory specimen.Fda safety report id# (b)(4).

• Brand Name: Q-TIP
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 10747507
• MDR Text Key: 213671639
• Report Number: MW5097477
• Device Sequence Number: 2
• Product Code: KXG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/25/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other