BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOUCH N' HEAT

    MDR report key: 3307072 · Received August 26, 2013

    Report

    Report Number
    2016150-2013-00101
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Report Date
    July 26, 2013
    Manufacturer
    SYBRONENDO
    Product Code
    EAT
    PMA / PMN Number
    K963862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS RECEIVED WITH REGARD TO THIS INCIDENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT IN ORDER TO OBTAIN FURTHER INFORMATION; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. A VISUAL AND PHYSICAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT A SPRING WAS BENT ON THE DEVICE, CAUSING CONSTANT HEATING.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE HAD ALLEGED THAT TWO (2) TOUCH N' HEAT UNITS HAD CONTINUED HEATING UP WHEN NOT IN USE AND PLUGGED IN. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415606 TOUCH N' HEAT PULP TESTER EAT SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other