MAUDE Adverse Event Report: SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Headache (1880); Tinnitus (2103); Foreign Body In Patient (2687)

Event Date 04/06/2021

Event Type  Injury  

Event Description

Infectious disease parasite; my pcp coerced me into getting a pcr test and i have reason to believe it caused foreign substances to be put in my nasal cavity.I have microscopic pictures of the substances.The pcr tests are not for diagnostic testing use, but they were used as such.The pcr test caused me to have frequent headaches and constant ringing in my ears (which was reported to my pcp).I attempted to find out exact information (manufacturer, lot number, etc) on the test swab used at the time i had the pcr test, but was told they couldn't tell me.I even contacted the supply department & was told the same thing.I am giving you a web address of a video that i have saved on a thumb drive as "possible evidence" of what may have been on that test swab, but i do have actual pictures from my microscope of my nasal mucus and back of throat mucus which both have the substances in them.I am attaching pictures from my own microscope of nasal mucus and back of throat mucus which both have substances in them.Fda safety report id# (b)(4).

• Brand Name: SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 12703640
• MDR Text Key: 278809841
• Report Number: MW5104954
• Device Sequence Number: 2
• Product Code: KXG
• 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: 10/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 82