BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY HEARING SCREENER

    MDR report key: 1665139 · Received April 19, 2010

    Report

    Report Number
    1419887-2010-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2010
    Date of Event
    February 1, 2008
    Report Date
    April 19, 2010
    Manufacturer
    SONAMED CORP.
    Product Code
    GWJ
    PMA / PMN Number
    K952080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMED OF INCIDENT BY (B)(4) REPRESENTATIVE ON (B)(6) 2010 AND NOT BY THE USER FACILITY. INCIDENT OCCURRED AT (B)(6), IN PER (B)(4) REPRESENTATIVE. INITIAL CONTACT WITH THE AUDIOLOGIST AT (B)(6) WAS MADE WITH A REQUEST FOR INFORMATION ON THE INCIDENT. SUBSEQUENT INFORMATION REQUESTS HAVE NOT BEEN ANSWERED, THEREFORE DEFINITIVE EVIDENCE OF THE POTENTIAL FOR AND EXTENT OF ANY IMPAIRMENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AS NATUS WAS FIRST INFORMED ON (B)(6) 2010, AN INFANT (B)(6) 2008 RECEIVED A BILATERAL PASS ON CLARITY OAE SCREENING PRIOR TO HOSPITAL DISCHARGE. NOTING A FAILURE TO DEVELOP AUDITORY LANGUAGE SKILLS, AUDIOLOGICAL EVALUATION WAS UNDERTAKEN IN (B)(6) 2009 WHEN THE CHILD WAS (B)(6). THE RESULTS INDICATED PROFOUND BILATERAL LOSS WITH NO RESIDUAL HEARING AND THE CHILD WAS SENT FOR COCHLEAR IMPLANT EVALUATION. CT SCANS PERFORMED AS IS STANDARD PRACTICE DURING THAT PROCESS REVEALED THAT THE COCHLEA IS ABSENT BILATERALLY. ALTHOUGH REPEATED ATTEMPTS HAVE BEEN MADE, INFORMATION IS NOT CURRENTLY AVAILABLE ON THE OUTCOME, IF ANY, OF THE COCHLEAR IMPLANT EVALUATION. IT IS NOT CLEAR BY THE ABOVE INFORMATION IF THERE IS A POTENTIAL FOR OR THE EXTENT OF ANY IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY HEARING SCREENER GWJ SONAMED CORP. TCP-240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other CURRENTLY UNK