BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAE PEDIATRIC FOAM EAR TIPS

    MDR report key: 7081404 · Received December 4, 2017

    Report

    Report Number
    3018859-2017-01012
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Report Date
    November 7, 2017
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS INVESTIGATED THROUGH CORRECTIVE ACTIONS. THE ROOT CAUSE OF THIS ISSUE WAS CONFIRMED TO BE INADEQUATE APPLICATION OF THE ADHESIVE WHICH SECURES THE FOAM TO THE LUMEN TUBE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED REPLACEMENT FOAM TIPS, AND PRODUCT RETURNS HAVE BEEN REQUESTED. NATUS INSTRUCTIONS INCLUDE SELECTING THE APPROPRIATE SIZE EAR TIP FOR THE PATIENT, AS WELL AS INSTRUCTIONS REGARDING USING LARGER SIZE FOAM TIPS FOR INSERTION INTO THE EAR CANAL. NATUS IS INVESTIGATING THIS ISSUE THROUGH CORRECTIVE ACTIONS AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS MEDICAL THAT THE FOAM TIPS OF THE PEDIATRIC FOAM EAR TIPS ARE SEPARATING FROM THE INNER PLASTIC TUBING. THE CUSTOMER HAS ALSO REPORTED GLUE INSIDE THE INNER TUBING. THERE HAS BEEN NO REPORT OF PATIENT DEATH, INJURY OR DELAY IN PATIENT TREATMENT. NO ENVIRONMENTAL OR SAFETY CONCERNS HAVE ALSO BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860767 OAE PEDIATRIC FOAM EAR TIPS OAE PEDIATRIC FOAM EAR TIPS GWJ NATUS MEDICAL INC. 203211 N050217-05

    Patients

    Seq Age Sex Outcome Treatment
    1 Other