BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE MEDIC

    MDR report key: 8050231 · Received November 8, 2018

    Report

    Report Number
    3010078417-2018-00013
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    September 30, 2018
    Report Date
    March 15, 2019
    Manufacturer
    ACTEGY LTD
    Product Code
    NGX
    PMA / PMN Number
    K152480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVITIVE MEDIC HAS A USER INTERFACE AND REMOTE CONTROL WHICH THE USER CAN INCREASE OR DECREASE THE STIMULATION INTENSITY. THE DEVICE IS DESIGNED SO THAT STIMULATION INTENSITY CAN ONLY BE INCREASED IN STEPS OF 10. FOR EXAMPLE, IF THE CUSTOMER WANTED TO INCREASE THE INTENSITY FROM 10 TO 99 BY KEEPING HIS FINGER ON THE REMOTE CONTROL AS CLAIMED BY THE CUSTOMER HE WOULD HAVE HAD TO TAKE HIS FINGER OFF THE BUTTON AND THEN PRESS IT AGAIN TO INCREASE TO THE MAXIMUM INTENSITY STEP OF 20 AND INCREMENTALLY UP TO 90. THE INSTRUCTIONS FOR USE CLEARLY PROVIDES THE FOLLOWING CAUTION: PLEASE READ THE USER'S MANUAL CAREFULLY BEFORE USING THIS PRODUCT BE CAREFUL WHEN APPLYING STIMULATION OVER AREAS OF SKIN THAT LACK NORMAL SENSATION. THIS PRODUCT IS NOT INTENDED FOR USE BY PERSONS WITH REDUCED PHYSICAL, SENSORY OR METAL CAPABILITIES, UNLESS THEY ARE SUPERVISED BY A PERSON RESPONSIBLE FOR THEIR SAFETY. THE DEVICE WAS RETURNED TO OUR WAREHOUSE UNDER RMAUS26986 ON THE 11TH OCTOBER 2018. HOWEVER THE INCIDENT WAS NOT REPORTED UNTIL THE 19TH OCTOBER 2019. IN THAT TIME THE DEVICE WAS PUT BACK INTO INVENTORY AND SENT TO ANOTHER CUSTOMER AND UNFORTUNATELY WE HAVE NOT BEEN ABLE TO LOCATE THE CURRENT LOCATION. THE INCIDENT WAS ONLY REPORTED AFTER THE CUSTOMER WAS REFUSED A REFUND.

    Description of Event or Problem · 0

    ON OCTOBER 19 CUSTOMERS SON MR (B)(6) CALLED TO REPORT HIS FATHER (B)(6) ATTEMPTED TO USE THE DEVICE ON (B)(6) BUT COULD NOT FEEL ANYTHING SO TURNED THE INTENSITY UP TO 90 AND THEN PLACED FEET ON MACHINE. IT WAS TOO POWERFUL AND CAUSED HIM TO FALL AND HIT HIS HEAD, CAUSING HIM TO HAVE A STROKE. WHEN THE DEVICE INTENSITY WAS SET TO 60 THE CUSTOMER CLAIMED HE COULD NOT FEEL ANY STIMULATION AND THEREFORE KEPT HIS THUMB ON THE REMOTE CONTROL INCREASING THE INTENSITY TO 90. THE CUSTOMER REPORTED TO BE IN GENERALLY GOOD HEALTH BUT IS SUFFERING FROM NEUROPATHY AND UNABLE TO DRIVE. PRIOR TO THE REPORTED INCIDENT THE CUSTOMER REPORTED USING THE DEVICE 3 TIMES A WEEK FOR 15 MINUTES AT INTENSITY SETTING 60. THE SON IS NOW REPORTING HIS FATHER HAS BEEN PUT IN AN ASSISTED CARE FACILITY AND MEDICARE IS HANDLING AS A CASE FOR ABUSE OF THE ELDERLY. CUSTOMER LOOKING FOR REFUND TO HELP COVER COSTS FOR ASSISTED CARE EXPENSES, STATING THAT HIS FATHER IS IN ASSISTED CARE NOW ONLY BECAUSE THE REVITIVE MACHINE CAUSED HIM TO FALL AND HIT HIS HEAD.

    Additional Manufacturer Narrative · 1

    THE REVITIVE MEDIC HAS A USER INTERFACE AND REMOTE CONTROL WHICH THE USER CAN INCREASE OR DECREASE THE STIMULATION INTENSITY. THE DEVICE IS DESIGNED SO THAT STIMULATION INTENSITY CAN ONLY BE INCREASED IN STEPS OF 10. FOR EXAMPLE, IF THE CUSTOMER WANTED TO INCREASE THE INTENSITY FROM 10 TO 99 BY KEEPING HIS FINGER ON THE REMOTE CONTROL AS CLAIMED BY THE CUSTOMER HE WOULD HAVE HAD TO TAKE HIS FINGER OFF THE BUTTON AND THEN PRESS IT AGAIN TO INCREASE TO THE MAXIMUM INTENSITY STEP OF 20 AND INCREMENTALLY UP TO 90. THE INSTRUCTIONS FOR USE CLEARLY PROVIDES THE FOLLOWING CAUTION: PLEASE READ THE USER'S MANUAL CAREFULLY BEFORE USING THIS PRODUCT BE CAREFUL WHEN APPLYING STIMULATION OVER AREAS OF SKIN THAT LACK NORMAL SENSATION. THIS PRODUCT IS NOT INTENDED FOR USE BY PERSONS WITH REDUCED PHYSICAL, SENSORY OR METAL CAPABILITIES, UNLESS THEY ARE SUPERVISED BY A PERSON RESPONSIBLE FOR THEIR SAFETY.

    Description of Event or Problem · 1

    ON OCTOBER 19 CUSTOMERS SON ((B)(6)) CALLED TO REPORT HIS FATHER ((B)(6)) ATTEMPTED TO USE THE DEVICE ON SEPTEMBER 30 BUT COULD NOT FEEL ANYTHING SO TURNED THE INTENSITY UP TO 90 AND THEN PLACED FEET ON MACHINE. IT WAS TOO POWERFUL AND CAUSED HIM TO FALL AND HIT HIS HEAD, CAUSING HIM TO HAVE A STROKE. WHEN THE DEVICE INTENSITY WAS SET TO 60 THE CUSTOMER CLAIMED HE COULD NOT FEEL ANY STIMULATION AND THEREFORE KEPT HIS THUMB ON THE REMOTE CONTROL INCREASING THE INTENSITY TO 90. THE CUSTOMER REPORTED TO BE IN GENERALLY GOOD HEALTH BUT IS SUFFERING FROM NEUROPATHY AND UNABLE TO DRIVE. PRIOR TO THE REPORTED INCIDENT THE CUSTOMER REPORTED USING THE DEVICE 3 TIMES A WEEK FOR 15 MINUTES AT INTENSITY SETTING 60. THE SON IS NOW REPORTING HIS FATHER HAS BEEN PUT IN AN ASSISTED CARE FACILITY AND MEDICARE IS HANDLING AS A CASE FOR ABUSE OF THE ELDERLY. CUSTOMER LOOKING FOR REFUND TO HELP COVER COSTS FOR ASSISTED CARE EXPENSES, STATING THAT HIS FATHER IS IN ASSISTED CARE NOW ONLY BECAUSE THE REVITIVE MACHINE CAUSED HIM TO FALL AND HIT HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889411 REVITIVE MEDIC CIRCUALTION BOOSTER NGX ACTEGY LTD 2469MD N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L