MAUDE Adverse Event Report: UNILEVER Q TIP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2021

Event Type  Injury  

Event Description

Used q tip brand cotton swab inside ear.Cotton tip fell off in both ears and remained in both ears.Seeking medical appointment to extract.(b)(4) stamped on package.

• Brand Name: Q TIP
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): UNILEVER ; 800 sylvan ave; englewood cliffs NJ 07632
• MDR Report Key: 12342850
• MDR Text Key: 267626600
• Report Number: MW5103345
• Device Sequence Number: 1
• Product Code: KXF
• 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: 08/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 83