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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Malaise (2359); Blood Loss (2597)

Event Date 07/07/2020

Event Type  Injury  

Event Description

Remdesivir treatment under emergency use authorization (eua): i'm unsure if this is the correct one, but i had mandatory covid testing at my job 2 days ago.After she did my swab, my nose began to bleed profusely without stopping.Later i became dizzy.Then after it finally quit, 2 hours later started again.After being off for my two days, i began having cold symptoms.Not sure, (b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID NASAL SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 10270032
• MDR Text Key: 198880263
• Report Number: MW5095497
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 95