MAUDE Adverse Event Report: APOTHECARY PRODUCTS, LLC FLENTS QUIET PLEASE FOAM EAR PLUG

Model Number F408-150

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

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 12/11/2019

Event Type  Injury  

Event Description

The customer stated they experienced an ear infection after first use of the ear plugs, which required a visit to the doctor and a prescription of antibiotics.

• Brand Name: FLENTS QUIET PLEASE FOAM EAR PLUG
• Type of Device: FOAM EAR PLUG
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC; 11750 12th ave s; burnsville MN 55337
• Manufacturer Contact: paxia her ; 11750 12th ave s; burnsville, MN 55337
• MDR Report Key: 9511182
• MDR Text Key: 172599555
• Report Number: 0002183416-2019-00008
• Device Sequence Number: 1
• Product Code: EWD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F408-150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention