BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEEQ

    MDR report key: 7101744 · Received December 8, 2017

    Report

    Report Number
    3010824444-2017-00010
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    October 7, 2017
    Report Date
    December 8, 2017
    Manufacturer
    EPIC TECHNOLOGIES, LLC
    Product Code
    DSI
    PMA / PMN Number
    K133701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVAL OTHER DESCRIPTION: PHYSICAL PRODUCT ANALYSIS IS NOT REQUIRED FOR SKIN DISCOMFORT/IRRITATION COMPLAINTS BECAUSE THERE IS NO WAY TO DETERMINE THE LEVEL OF SKIN DISCOMFORT/IRRITATION THROUGH ANALYSIS OF THE PHYSICAL PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REMOVED THE WEARABLE SENSOR AND "EXPERIENCED 3RD DEGREE BURNS FROM METAL." IT IS UNKNOWN IF THE SENSOR WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880549 SEEQ DETECTOR AND ALARM, ARRHYTHMIA DSI EPIC TECHNOLOGIES, LLC P01575-010

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other