MAUDE Adverse Event Report: COPAN ITALIA FLOQSWABS; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number 502CS01

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Dyspnea (1816); Emotional Changes (1831); Nausea (1970); Skin Discoloration (2074); Tachycardia (2095); Burning Sensation (2146); Dizziness (2194); Nasal Obstruction (2466)

Event Date 11/12/2021

Event Type  Injury  

Event Description

After floqswab, had a reaction.Elevated heart rate, dizziness, nausea, diarrhea, flushed face, burning nose, jittery overall not well, feeling shortness of breath, nose very congested.Fda safety report id # (b)(4).

• Brand Name: FLOQSWABS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): COPAN ITALIA
• MDR Report Key: 12877783
• MDR Text Key: 281324470
• Report Number: MW5105578
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 502CS01
• Device Catalogue Number: CE0123
• Device Lot Number: 196M20 L. 2111658
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose