BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAE PEDIATRIC FOAM EAR TIPS

    MDR report key: 7023272 · Received November 10, 2017

    Report

    Report Number
    3018859-2017-00891
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Report Date
    October 12, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PART WAS SENT, RESOLVING CUSTOMER ISSUE. NATUS HAS REQUESTED THE AFFECTED LOT CONTAINING THE FOAM TIPS FOR FURTHER INVESTIGATION OF THIS COMPLAINT. 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. SUPPLEMENTAL REPORT WILL BE SUBMITTED AS NEEDED.

    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.

    Description of Event or Problem · 1

    NATUS MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2017. THAT THEIR OAE PEDIATRIC FOAM TIP ARE REMAINING IN THE PATIENT EAR WHILE THE PROBE IS BEING REMOVED FROM THE PATIENT EAR. THE CUSTOMER CONFIRMED THAT THERE WAS PATIENT INVOLVEMENT BUT NO DEATH/SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796571 OAE PEDIATRIC FOAM EAR TIPS OAE PEDIATRIC FOAM EAR TIPS GWJ NATUS MEDICAL INCORPORATED 203211 N050217-05

    Patients

    Seq Age Sex Outcome Treatment
    1