BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIVAMAT 200

    MDR report key: 2623682 · Received May 23, 2012

    Report

    Report Number
    3002892330-2012-00001
    Event Type
    Other
    Date Received
    May 23, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 16, 2012
    Manufacturer
    PHYSIOMED ELEKTROMEDIZIN AG
    Product Code
    ISA
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HIVAMAT 200 DEVICES HAVE BEEN ON THE MARKET FOR 20 YEARS (EUROPE), RESPECTIVELY SINCE 2004 (USA). A COMPARABLE SIDE EFFECT OR EVENT AS THE ONE DESCRIBED HAS NEVER BEEN REPORTED TO THE MFR. FROM OUR EXPERIENCE AND THE EXPERIENCE OF OUR MEDIAL CONSULTANTS, IT IS VERY UNLIKELY THAT THE PHYSIOLOGICAL EFFECT OF THE DEVICE CAN BE THE CAUSE OF A SYMPTOMATOLOGY AS DESCRIBED BY THE PT. THE DEVICE HAS A VERY LOW RISK LEVEL AND IS CLASSIFIED AS CLASS I DEVICE, EXEMPT, REGISTERED WITH FDA AS SUCH THE LADY HAS A VERY LONG LIST OF MEDICAL COMPLAINTS, ONE OF WHICH OR SEVERAL OF WHICH MIGHT BE THE CAUSE OF THE PAIN WHICH SHE CONTINUES TO FEEL; WE ARE NOT ABLE TO COMPREHEND OR TO VERIFY THE PAIN OR SWELLING. WE WERE INFORMED ABOUT THE EVENT FOR THE FIRST TIME IN THE MIDDLE OF JANUARY 2012. AT THAT TIME WE DID NOT HAVE THE DETAILS WE KNOW TODAY. WITH THE INFO WE HAD THEN WE DID NOT SEE A REASON TO MAKE A REPORTING TO THE FDA YET. LATER WE WERE INFORMED THAT THE EVENT OCCURRED DURING/AFTER A TRAINING WITH THE DEVICE FOR A CLINIC¿S MEDICAL PERSONNEL. THE TRAINER IS A PERSON WHO HAS ALREADY BEEN IN CONTACT WITH THE MEDICAL TEAM FOR YEARS AND HAD CONDUCTED SEVERAL PREVIOUS TRAININGS WITH THE TEAM SINCE 2010. THE PT IN QUESTION IS A MEMBER OF THIS TEAM. SHE HAD PREVIOUSLY UNDERGONE SEVERAL HIVAMAT 200 TREATMENTS FOR PAIN AND A SWOLLEN KNEE, WHICH ALL WERE SUCCESSFUL AND WITHOUT COMPLAINTS. IN JANUARY THE PT REPORTED UNCOMFORTABLE SENSATIONS DURING AND PAIN AFTER THE TRAINING SESSION (EVENT). IT MUST BE TAKEN INTO ACCOUNT THAT THE PT HAS A LONG MEDIAL HISTORY OF DIFFERENT DIAGNOSES. THE DEVICE IN QUESTION WAS TESTED. NO IRREGULARITIES OR DEVIATIONS WERE OBSERVED.

    Description of Event or Problem · 1

    PAIN IN RIGHT AREA OF LEG/HIP, INGUINAL, QUADRICEPS RADIATING TO KNEE, ALSO LUMBARCOXIC PAIN, PAIN AFTER TREATMENT (TREATMENT WAS AFTER TRAINING WITH THE DEVICE, TRAINEE 3 PEOPLE, TRAINING ON THAT PERSON SEVERAL TIMES) LATER COLD SHIVERING AND COLD EXTREMITIES, SWELLING (LATER) WE ARE NOT ABLE TO COMPREHEND OR VERIFY THE DESCRIBED SWELLING OR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIVAMAT 200 HIVAMAT 200 ISA PHYSIOMED ELEKTROMEDIZIN AG 050

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other LASER THERAPY ( NO DETAILS KNOWN)| ESTRADIOL 1MG