MAUDE Adverse Event Report: SARS COV 2 TESTING KITS; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Headache (1880); Pain (1994); Rash (2033); Burning Sensation (2146); Cognitive Changes (2551); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/04/2022

Event Type  Injury  

Event Description

Weekly nasal testing from a variety of pcr/rapid testing for sars cov 2.Headaches, nasal burning, nasal rash, vibration/buzzing bees feeling behind the nose, sinus pressure, eye strain, brain fog, upper jaw pain.After several days of these things occurring, they would disappear only to reoccur immediately to 24 hours after another test was completed.County/school/and pharmacy provided kits.All brands.Fda safety report id# (b)(4).

• Brand Name: SARS COV 2 TESTING KITS
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 14565795
• MDR Text Key: 293160392
• Report Number: MW5109999
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• 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: 05/26/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female