BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1832415-2017-08675

    MDR report key: 7946333 · Received October 9, 2018

    Report

    Report Number
    1832415-2017-08675
    Event Type
    Injury
    Date Received
    October 9, 2018
    Report Date
    December 7, 2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED "RECEIVING A SHOCK FEELING UP HER ARM WHEN PRESSING THE TRIGGER." THE PRODUCT WAS RETURNED FOR INVESTIGATION. AN INVESTIGATION WAS DONE INTO THE CUSTOMERS COMPLAINT, AND THE INSPECTOR DID NOT FIND ANY SIGNS OF THE SWITCH/PAD SHOCK. ADDITIONALLY, THE CUSTOMER WAS MISUSING THE PAD. THE PAD WAS BUNCHED. THE LEADS WERE BENT, THE THERMOSTATS WERE BENT. DEFECTS LIKE THESE ARE TYPICALLY SEEN IN PRODUCT THAT HAS BEEN FOLDED OR LAID ON WHILE BEING IN USE. BASED ON THE BCE REVIEW OF FEEDBACKS, BCE DID NOT OBSERVE A SIMILAR ISSUE WITHIN THE LOT.

    Patients

    Seq Age Sex Outcome Treatment
    0