BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE FACE

    MDR report key: 5382427 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00025
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NFO
    PMA / PMN Number
    K103031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS PROVIDED TO (B)(4) VIA SOCIAL MEDIA AND NO CUSTOMER CONTACT INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED FOR TESTING AND THE ROOT CAUSE COULD NOT BE ESTABLISHED. THIS COMPLAINT HAS BEEN REPORTED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS REPRESENTING EVENTS THAT ARE MDR REPORTABLE.

    Description of Event or Problem · 1

    (B)(4) WAS NOTIFIED ON (B)(6) 2014, VIA EMAIL FROM A TRADE CUSTOMER, OF A COMPLAINT THROUGH IT'S SOCIAL MEDIA. A CUSTOMER HAD REPORTED THAT ON USE OF THE SLENDERTONE FACE FOR 2 -3 WEEKS, HE/SHE HAD EXPERIENCED A BROKEN PORCELAIN CROWN AND A LOOSE BRIDGE. NO CUSTOMER CONTACT DETAILS WERE PROVIDED TO (B)(4) AND NO FURTHER MEDICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41482 SLENDERTONE FACE FACIAL STIMULATOR NFO BIO-MEDICAL RESEARCH LTD 371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other