MAUDE Adverse Event Report: CVS BABY SAFETY COTTON SWABS ; APPLICATOR, ABSORBENT; TIPPED, NON-STERILE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2019

Event Type  Injury  

Event Description

Caller is reporting that cotton swabs she purchased are unsafe because the stems are pushing through the cotton swabs which can puncture the ear.She is concerned that if used on a child or infant could cause serious injuries.Caller stated that she returned the original box but the second box she purchased had the same problem.Caller feels that these cotton swabs are a safety hazard and should be reported.Document number: (b)(4).Report number: (b)(4).Retailer: (b)(6).Retailer state: (b)(6).Purchase date: 09/28/2019.The product was damaged before the incident: no.The product was modified before the incident: no.

• Brand Name: CVS BABY SAFETY COTTON SWABS
• Type of Device: APPLICATOR, ABSORBENT; TIPPED, NON-STERILE
• MDR Report Key: 9180098
• MDR Text Key: 162343380
• Report Number: MW5090353
• 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: Patient
• Type of Report: Initial
• Report Date: 10/01/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1