BEUDAMED
    FDA Adverse Event Death Summary report: N

    REXTON

    MDR report key: 541793 · Received August 31, 2004

    Report

    Report Number
    1419512-2004-00001
    Event Type
    Death
    Date Received
    August 31, 2004
    Date of Event
    June 25, 2004
    Report Date
    August 31, 2004
    Manufacturer
    REXTON, INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 08/2004, MFR WAS PLACED ON NOTICE OF A POTENTIAL EXPOSURE BASED ON ALLEGATIONS MADE BY A CLAIMANT'S SURVIVING SPOUSE. ALLEGES THE HEARING AID WAS THE PROXIMATE CAUSE OF THE MOTOR VEHICLE ACCIDENT THAT RESULTED IN PT'S DEATH. THIS ACCOUNT OF THE INCIDENT IS DERIVED SOLELY FROM NOTES TAKEN DURING A TELEPHONE INTERVIEW BETWEEN THE SPOUSE AND THE RISK MANAGER. PT PURCHASED ITEM #661677 REXRGTA2BTE HEARING AID (QUANTITY 2) IN 05/04. ACCORDING TO THE PHONE CALL WITH SPOUSE, PT RETURNED 2 TIMES TO HAVE THE HEARING AIDS ADJUSTED FOR "RINGING." PT AND SPOUSE ALONG WITH THEIR TWO FAMILY MEMBERS WERE INVOLVED IN A ONE VEHICLE ROLL OVER ACCIDENT WHILE DRIVING. SPOUSE REMEMBERS THAT THE HEARING AIDS STARTED TO "RING" SO LOUD THAT THE CAR STARTED TO VIBRATE AND THAT WHILE PT WAS TRYING TO PULL HEARING AIDS OUT, PT LOST CONTROL OF THEIR VEHICLE AND WAS KILLED. SPOUSE WAS IN ICU FOR A MONTH WITH EXTENSIVE INJURIES, AND ONE FAMILY MEMBER HAS HAD 4 SURGERIES AND THE SECOND HAS HAD 5 SURGERIES WITH MORE ANTICIPATED. THE THREE SURVIVORS WERE TRAPPED IN THE VEHICLE AND THE JAWS OF LIFE WAS USED TO GET THEM OUT. THIS INFO IS BASED STRICTLY FROM SPOUSE'S RECOLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REXTON BEHIND THE EAR HEARING AID (BTE) ESD REXTON, INC. REGATTA-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death