MAUDE Adverse Event Report: COVID-19 SCREENING TEST, NASAL SWAB; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Nausea (1970); Pain (1994)

Event Date 07/06/2020

Event Type  Injury  

Event Description

Covid-19 screening test, nasal swab.Within 5 minutes, sore neck, sore muscle in back on the side where swab taken.Light headache.Slight sense of nausea.Overall sense of fatigue.Ate food and symptoms improved, but symptoms returned.Somewhat similar to low blood pressure or dehydration.Do not feel faint, but very tired.Feel need to lean on things when standing.Now 1.5 hours later.

• Brand Name: COVID-19 SCREENING TEST, NASAL SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 10244623
• MDR Text Key: 198107564
• Report Number: MW5095397
• Device Sequence Number: 1
• Product Code: KXF
• 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: 07/06/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 74