BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYA-PULSE -DYNAPULSE--NOT SURE-

    MDR report key: 746939 · Received October 1, 2005

    Report

    Report Number
    MW1036794
    Event Type
    Other
    Date Received
    October 1, 2005
    Date of Event
    October 10, 2004
    Report Date
    October 1, 2005
    Manufacturer
    UNK
    Product Code
    LXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOLLOWING EYE SURGERY FOR EYE LID LIFT, MY CHIROPRACTOR SUGGESTED USING HIS MACHINE, DYNAPULSE, TO HELP MY INCISIONS HEAL FASTER. I HAD THREE OR FOUR SESSIONS WITH HIM WHERE HE TARGETED THE MACHINE ON MY EYES. THE PLASTIC SURGEON COMMENTED THAT HE HAD NOT SEEN ANYONE HEAL QUITE SO FAST; HOWEVER, FOLLOWING THE TREATMENTS I HAVE INCREASED PROBLEMS WITH DRY EYES. THE CHIROPRACTOR HAD SHOWED ME PHOTOS OF A DIFFERENT WOMAN WHO HAD SIMILAR SURGERY AND HAD USED THE MACHINE. HER EYES LOOKED RED AND HE SAID HE HAD HELPED HER. I DID NOT GET HER NAME AND HE TOLD ME THAT SHE HAS SINCE PASSED AWAY--SO I DON'T KNOW WHAT HER OUTCOME WAS. HE TOLD ME THE MACHINE WOULD NOT BE AS HOT AS DIATHERMY, BUT THE MACHINE WAS PLACED CLOSE TO MY EYES. ANOTHER CHIROPRACTOR IN WITH HIM HAD CUT HIMSELF AND HAD STITCHES. HE USED THE DYNAPULSE ON HIS CUT AND WAS ABLE TO REMOVE THE STITCHES THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYA-PULSE -DYNAPULSE--NOT SURE- UNSURE LXF UNK NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other