BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE BOTTOM

    MDR report key: 5382431 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00027
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    November 1, 2014
    Report Date
    February 27, 2015
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K072294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL REPORT WAS PROVIDED FOR THIS INVESTIGATION. TESTING WAS COMPLETED ON THE DEVICE AND IT WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMS THAT THE DEVICE HAS MET ITS MANUFACTURING SPECIFICATIONS. ADVERSE REACTIONS OF SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS. THIS RISK HAS BEEN DOCUMENTED IN THE RISK ASSESSMENT AND ALSO USER INSTRUCTIONS FOR USE OF THE DEVICE. ' A SMALL NUMBER OF ISOLATED SKIN REACTIONS HAVE BEEN REPORTED BY PEOPLE USING MUSCLE STIMULATION DEVICES, INCLUDING ALLERGIES, A PROLONGED REDDENING OF THE SKIN AND ACNE'. 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

    BIO-MEDICAL RESEARCH LTD. WAS NOTIFIED ON (B)(6) 2015, VIA EMAIL, OF A COMPLAINT REGARDING THE SLENDERTONE BOTTOM DEVICE. A (B)(6) OLD FEMALE CUSTOMER REPORTED A RASH AFTER FIRST USING THE DEVICE IN (B)(6) 2014. THE RASH WAS LOCATED AROUND THE UPPER GEL PADS AREA. THE CUSTOMER STOPPED USING THE DEVICE FOR A COUPLE OF WEEKS AND CHANGED THE PADS. AS SOON AS THE SHE REUSED THE DEVICE, THE RASH APPEARED. THE CUSTOMER VISITED HER GP AND WAS GIVEN AN OINTMENT TO USE ON THE AREAS AFFECTED (AREAS COVERED BY THE UPPER PADS AND ONE AREA UNDER THE LOWER RIGHT PAD). THE CUSTOMER WAITED FOR THE RASH TO DISAPPEAR AND STARTED AGAIN IN (B)(6) 2015 AND THE RASH REAPPEARED. THE CUSTOMER VISITED HER GP ON (B)(6) 2015 AND WAS TOLD TO DISCONTINUE USING THE DEVICE AND WAS GIVEN A CREAM TO USE FOR 2 WEEKS. THE CUSTOMER HAS USED THE OINTMENT FOR 4 WEEKS AND RASH HAS DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40617 SLENDERTONE BOTTOM POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 396

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other