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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  No Answer Provided  

Event Description

Did not invade sinus area on (b)(6) 2021.Both nasal swabbings, on (b)(6) 2021, did not invade sinuses.Received proper swabbing on (b)(6) at (b)(6) arena testing for covid-19 antibodies.Will not get results until 2 weeks around (b)(6) 2021.

• Brand Name: NASAL SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 12512792
• MDR Text Key: 272887111
• Report Number: MW5104114
• Device Sequence Number: 3
• 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: 09/18/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 64