MAUDE Adverse Event Report: APOTHECARY PRODUCTS, LLC FLENTS; EAR STOPPLES

Model Number F402-122

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

Patient Problem Unspecified Infection (1930)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Apothecary products was acquired in february 2014 following which a new management team was established.This included a new regulatory and quality systems team.As part of this transition a regulatory and quality system compliance assessment was conducted, which included a three-year retrospective review of complaints from 1 january 2014 to 31 may 2018 to ensure that reported events that meet the reporting requirements of 21 cfr part 803 medical device reporting (mdr) regulation were notified to the fda.During this review we identified 5 complaints that we believe meet the reporting criteria which were not reported to the fda and are being reported to the fda at this time.New procedures have been implemented to ensure that events that meet the reporting criteria requirements of 21 cfr part 803 are reported to the fda in accordance with regulatory requirements.

Event Description

User reported the ear stopples gave her an ear infection.She went to the doctor and was prescribed drops and antibiotic.

• Brand Name: FLENTS
• Type of Device: EAR STOPPLES
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC; 11750 12th ave s.; burnsville MN 55337
• Manufacturer Contact: paxia her ; 11750 12th ave s.; burnsville, MN 55337 ; 9528088364
• MDR Report Key: 7974266
• MDR Text Key: 123987125
• Report Number: 0002183416-2018-00005
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: F402-122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR