BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE MALE FACE

    MDR report key: 5382478 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00024
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K103031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER CONTACTED CALL CENTRE TO REPORT HE SUFFERED A DETACHED RETINA AFTER USING THE DEVICE. HE STATED HE DID NOT WISH TO PURSUE A MEDICAL COMPLAINT AND WAS ONLY HIGHLIGHTING THE ISSUE. CONSUMER LEFT NO NAME OR CONTACT DETAILS AND DID NOT WISH TO BE CONTACTED FURTHER. NO MEDICAL REPORT / EVALUATION WAS PROVIDED. DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS COULD NOT BE EVALUATED AS NO SERIAL NUMBER WAS PROVIDED. A CONVERSATION WAS HELD BETWEEN BMRS SENIOR CLINICAL SCIENTIST AND A CONSULTANT OPHTHALMIC SURGEON IN THE GALWAY CLINIC IN RELATION TO SLENDERTONE FACE DEVICE AND OTHER FACIAL TONING DEVICES AND THE CLINICAL POSSIBILITY OF INDUCING RETINAL DETACHMENT. THE SURGEON INDICATED TO ESTABLISH A DIRECT CASUAL LINK ONE WOULD HAVE TO DEMONSTRATE A TRANSIENT RISE IN PRESSURE OR TANGENTIAL FORCES ON THE EYES DURING THE DEVICE USE. ON REVIEWING THIS COMPLAINT, THE SURGEON REFERRED TO A CONDITION KNOWN AS ENTROPION WHERE THE EYELID MUSCLES BECOME MAL POSITIONED AND CAUSE THE EYELIDS TO TURN INWARDS CAUSING REDDING AND IRRITATION OF THE EYE. THE SURGEON BELIEVES RETINA DETACHMENT IS USUALLY ACCOMPANIED BY PRECEDING TRAUMA OR AN UNDERLYING CONDITION. IN SOME CASES WHERE A PERSON HAS AN UNDERLYING CONDITION, IT WOULD BE ADVISABLE TO CONSULT A QUALIFIED PROFESSIONAL BEFOREHAND, HOWEVER, HE DOES NOT BELIEVE THERE IS A DIRECT LINK BETWEEN THE SLENDERTONE FACE DEVICE AND THIS COMPLAINT. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CONSUMER CALLED THE CUSTOMER CARE TEAM TO SAY HE WAS CONVINCED HE HAD A DETACHED RETINA AFTER USING THE SLENDERTONE FACE PRODUCT. HE USED THE UNIT 3-4 TIMES AND EACH TIME HIS EYE BECAME VERY RED. HE ADVISED HE DID NOT WANT TO PURSUE A MEDICAL COMPLAINT AND DID NOT LEAVE HIS NAME AND NUMBER AS HE DID NOT WISH TO BE CONTACTED. HE WANTED TO MAKE THE COMPANY AWARE OF HIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42267 SLENDERTONE MALE FACE POWER MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 372

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other