BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOUNDS Z1

    MDR report key: 1172752 · Received September 22, 2008

    Report

    Report Number
    3005724187-2008-00010
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ZOUNDS, INC.
    Product Code
    ESD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND THE RECEIVER HUB WAS BROKEN AT THE POINT WHERE THE 2 HALVES ARE BONDED TOGETHER. THE HUB PLASTIC HAD CRACKS AT THE POINT OF SEPARATION WHERE THE LINK TUBING IS BONDED TO THE HUB. THERE WAS EVIDENCE OF ADHESIVE ON BOTH HALVES OF THE SEPARATED AREA. THE CAUSE OF THE SEPARATION IS EXCESSIVE FORCE BEING APPLIED TO THE HUB BY THE PT.

    Description of Event or Problem · 1

    PT REPORTS THAT THE LINK RECEIVER HUB SEPARATED AND THE FOAM SLEEVE AND PART OF THE RECEIVER HUB REMAINED IN EAR. PT WENT TO OCCUPATIONAL NURSE WHO REMOVED THE FOAM SLEEVE FROM THE EAR. NO INJURY OR ADVERSE SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOUNDS Z1 AIR CONDUCTION HEARING AID ESD ZOUNDS, INC. Z1 BTE 4163

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention