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

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 09/16/2020

Event Type  Injury  

Event Description

Slept it off.Incredible pain; lady stuck the swab in and it hurt so bad.Felt like she stabbed me.She did the other side and the pain almost made me puke.The pain was probably the worst thing i have felt.The mirena being put inside me didn't even hurt that bad.It was the worst test i have ever had.Fda safety report id# (b)(4).

• Brand Name: COVID 19 SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 10559614
• MDR Text Key: 207894944
• Report Number: MW5096748
• Device Sequence Number: 1
• Product Code: KXF
• 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: 09/16/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 89