BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER SILICONE EAR PLUG

    MDR report key: 7974092 · Received October 17, 2018

    Report

    Report Number
    0002183416-2018-00003
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    June 1, 2015
    Report Date
    October 16, 2018
    Manufacturer
    APOTHECARY PRODUCTS, LLC
    Product Code
    EWD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    USER STATED THAT WHILE USING THE SILICONE EAR PLUG IN THE SHOWER, IT "CAME APART" IN HIS EAR. HIS WIFE ATTEMPTED TO REMOVE THE SILICONE EAR PLUG WITH A TWEEZER. USER WENT TO THE DOCTOR TO HAVE THE SILICONE EAR PLUG REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816067 KROGER SILICONE EAR PLUG SILICONE EAR PLUGS EWD APOTHECARY PRODUCTS, LLC K10-67

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention