BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE FACE

    MDR report key: 5382412 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00013
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 1, 2011
    Report Date
    February 21, 2012
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NFO
    PMA / PMN Number
    K103031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE COMPLAINT IS INCONCLUSIVE. A CONVERSATION WAS HELD BETWEEN THE SENIOR CLINICAL SCIENTIST OF BIO-MEDICAL RESEARCH LTD. AND A CONSULTANT OPHTHALMIC SURGEON IN RELATION TO SLENDERTONE FACE DEVICE AND OTHER FACIAL TONING DEVICES AND THE CLINICAL POSSIBILITY OF INDUCING RETINAL DETACHMENT. THE SURGEON INDICATED THAT 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 REVIEW OF 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 IS ADVISABLE TO CONSULT A QUALIFIED PROFESSIONAL BEFOREHAND, HOWEVER, HE DOES NOT BELIEVE THERE IS A DIRECT LINK BETWEEN USE OF THE SLENDERTONE FACE DEVICE AND THIS COMPLAINT. THE DEVICE ITSELF WAS RETURNED TO BIO-MEDICAL RESEARCH LTD. FOR EVALUATION AND NO FAILURE WAS DETECTED. THIS COMPLAINT HAS BEEN REPORTED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS REPRESENTING EVENTS THAT ARE MDR REPORTABLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICE WAS CONFIRMED TO HAVE MET IT'S MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    BIO-MEDICAL RESEARCH LTD. WAS NOTIFIED ON THE FEBRUARY 21, 2012, VIA EMAIL, BY IT'S CALL CENTRE OF A COMPLAINT REGARDING THE SLENDERTONE FACE. A (B)(6) YEAR OLD FEMALE CUSTOMER HAD PURCHASED THE DEVICE IN MARCH 2011 AND HAD COMPLETED 50-60 SESSIONS IN TOTAL (APPROX. 2-3 TIMES PER WEEK). THE PATIENT HAS REPORTED THAT FOLLOWING PAIN IN HER EYES, SHE HAD VISITED A DOCTOR AND WAS SUBSEQUENTLY DIAGNOSED WITH RETINAL DETACHMENT IN HER RIGHT EYE. THE DOCTOR ADVISED HER NOT TO USE DEVICE AGAIN AND LASER PHOTOCOAGULATION TREATMENT WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41479 SLENDERTONE FACE FACIAL STIMULATOR NFO BIO-MEDICAL RESEARCH LTD 371

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention