BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIDS KROGER SILICONE EAR PLUGS

    MDR report key: 7974233 · Received October 17, 2018

    Report

    Report Number
    0002183416-2018-00001
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    August 26, 2018
    Report Date
    August 29, 2018
    Manufacturer
    APOTHECARY PRODUCTS, LLC
    Product Code
    EWD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE LABEL PROVIDES THE FOLLOWING INFORMATION: "THESE EAR PLUGS ARE SIZED TO COVER TINY EAR CANALS ONLY - USE OUR ADULT SIZE TO COVER LARGER EAR CANALS. DIRECTIONS FOR EFFECTIVE AND COMFORTABLE USE: WITH CLEAN HANDS, ROLL PLUG BETWEEN FINGERS TO SOFTEN. USE ENTIRE PLUG. SHAPE PLUGS INTO A BALL. PLACE PLUGS AGAINST EAR OPENINGS AND FLATTEN FIRMLY. JUST COVER EAR OPENING. DO NOT FORCE INTO EAR CANAL. SAFETY WARNINGS: NOT RECOMMENDED FOR OVERNIGHT USE, DIVING, PROLONGED UNDERWATER SWIMMING, OR DEPTHS OVER 10 FEET. ALTHOUGH THESE PLUGS ARE NOT INTENDED FOR USE AS HEARING PROTECTORS, THEY WILL HELP BLOCK SOUND WHEN PROPERLY SEALED. IN CASE OF AIRPLANE USE, REMOVE PRIOR TO DESCENT. IF YOU SHOULD EXPERIENCE PAIN OR DISCOMFORT WHEN USING THIS PRODUCT, PLEASE DISCONTINUE USE. CAUTION: INSPECT PRODUCT BEFORE USE AND REPLACE PLUGS IF THEY ARE DAMAGED OR SHOW SIGNS OF WEAR. NOT FOR PROLONGED USE. DO NOT CUT, STRETCH OR BREAK APART EAR PLUGS. IF NOT USED AS DIRECTED, EAR PLUG COULD BECOME TRAPPED IN EAR CANAL REQUIRING SURGICAL REMOVAL BY A QUALIFIED PROFESSIONAL. IF EAR PLUG HAS BECOME LODGED IN EAR CANAL, DO NOT TRY TO REMOVE WITH TWEEZERS OR ANY OTHER DEVICE. SEEK MEDICAL ATTENTION FOR PROPER REMOVAL. PLEASE NOTE - A FEW DAYS DELAY WILL CAUSE NO HARM. WARNING: KEEP EAR PLUGS AWAY FROM INFANTS AND SMALL CHILDREN AS THEY MAY GET CAUGHT IN THE WINDPIPE AND CREATE A CHOKING HAZARD. USE BY CHILDREN SHOULD BE CLOSELY SUPERVISED BY ADULTS."

    Description of Event or Problem · 1

    USER'S GUARDIAN STATED AFTER USE OF THE SILICONE EARPLUG, IT COULD NOT BE REMOVED FROM THE USER'S EAR CANALS AND KEPT BREAKING APART UPON REMOVAL. THE USER'S GUARDIAN STATED THEY TRIED USING TWEEZERS TO REMOVE THE EAR PLUGS. THE USER WENT TO THE EMERGENCY ROOM WHERE SUCTION METHODS WERE USED TO TRY TO REMOVE THE SILICONE EAR PLUGS. THE USER HAD TO GET THE SILICONE EAR PLUGS SURGICALLY EXTRACTED WITH ANESTHESIA FOR REMOVAL FROM THE EAR CANALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814969 KIDS KROGER SILICONE EAR PLUGS SILICONE EAR PLUGS EWD APOTHECARY PRODUCTS, LLC C265STKG

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention