BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONIC INNOVATIONS

    MDR report key: 3541721 · Received December 17, 2013

    Report

    Report Number
    1724310-2013-00001
    Event Type
    Other
    Date Received
    December 17, 2013
    Date of Event
    November 29, 2013
    Report Date
    December 17, 2013
    Manufacturer
    SONIC INNOVATIONS, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECORD INDICATES THAT THE HEARING CARE PROFESSIONAL, TOTAL HEARING CARE, SHARON STOOR, REPORTED THAT A PT, WEARING THE FLIP MODEL 60 RIC BTE HEARING INSTRUMENTS, REPORTED THAT A RECEIVER DOME CAME OFF THE RECEIVER (SPEAKER) AND REMAINED LODGED IN THE PT'S EAR CANAL. THIS EVENT REQUIRED INTERVENTION TO REMOVE THE DISLODGED DOME. THERE WAS NO INDICATION THAT THE REPORTED EVENT RESULTED IN A PT INJURY. NO DEVICES, AT THE TIME OF THIS REPORT, WERE RETURNED FOR EVALUATION. A REQUEST HAS BEEN MADE TO RECOVER THE DOME. THERE HAVE BEEN NO CLAIMS OF PRODUCT DEFECT OR PT INJURY RESULTING FROM THE EVENT. BASED ON THE INSTALLED CUSTOMER BASE, NO INTEROPERABILITY PROBLEMS, HAVE BEEN OBSERVED. NO EVALUATION RESULTS ARE AVAILABLE FROM THE ACTUAL DEVICE THAT CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE CUSTOMER ALERT (COMPLAINT) LOGS FOR THE CALENDAR YEAR 2013 SHOWS NO TRENDS OR ALERT CONDITIONS REQUIRING FURTHER INVESTIGATION AT THIS TIME. THE DOMES ARE CONSIDERED SERVICE ITEMS THAT REQUIRE PERIODIC REPLACEMENT. INSTRUCTIONS FOR SERVICING DOMES ARE INCLUDED IN THE INSTRUCTIONS FOR USE DOCUMENT INCLUDED WITH THE SALE OF HEARING INSTRUMENTS.

    Description of Event or Problem · 1

    PT REPORTED THAT DOME CAME DISLODGED FROM RECEIVER (SPEAKER) AND REMAINED IN THE EAR CANAL REQUIRING INTERVENTION TO REMOVE THE DOME. THE EVENT OCCURRED THE DAY AFTER THE (B)(6) HOLIDAY ((B)(6) 2013) REQUIRING THE PT TO SEEK MEDICAL ATTENTION AT THE EMERGENCY ROOM TO REMOVE THE DOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659849 SONIC INNOVATIONS HEARING AID ESD SONIC INNOVATIONS, INC. FLIP 60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention