BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POINPOINT LASER

    MDR report key: 1413565 · Received July 2, 2009

    Report

    Report Number
    MW5011876
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    February 26, 2009
    Report Date
    July 2, 2009
    Manufacturer
    PATHOLASE, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DR. USING THE NEW PINPOINT LASER PRODUCT BY FACILITY. TREATED MY THUMB NAIL AND THE AREA AROUND IT TO KILL A NAIL FUNGUS GROWING THERE. IMMEDIATELY AFTER THE PROCEDURE STARTED, I COMPLAINED THAT I WAS EXPERIENCING PAIN AND THE DOCTOR RECOMMENDED THAT HE PERFORM A PAIN BLOCK ON THE THUMB WHICH WE DID. AFTER THE PROCEDURE, I EXPERIENCED A SIGNIFICANT AMOUNT OF PAIN AS THE LOCAL BLOCK WORE OFF. AFTER IT WORE OFF, THE PAIN INCREASED AS THE PRESSURE OF FLUID BUILDUP UNDER THE NAIL INCREASED UNTIL THE SWELLING WAS SO BAD THAT I HAD TO HAVE HOLES DRILLED IN THE NAIL TO RELEASE THE PRESSURE. THE FLUID WAS BOTH CLEAR AND PARTIALLY BLOODY. TWO DAYS FOLLOWING THE TREATMENT, "THE WAS WHITE", THE SKIN UNDERNEATH APPARENTLY DESTROYED, AND THE AREA AROUND MY NAIL WAS BLISTERED AND BURNED. THE THUMB WAS NUMB, TINGLY, AND PAINFUL TO TOUCH. THIRTEEN DAYS FOLLOWING THE TREATMENT, A STAPH INFECTION ERUPTED UNDER THE NAIL WHICH REQUIRED COMPLETE REMOVAL OF THE NAIL AND AROUND OF ANTIBIOTICS. THE STAPH INFECTION WAS VERIFIED BY A LAB TEST. TODAY, JUST OVER 4 MONTHS FROM THE ORIGINAL EVENT, THE NAIL IS GROWING, BUT DOES NOT APPEAR TO BE GROWING BACK COMPLETELY AND IS DISFORMED. DATES OF USE: 2009. DIAGNOSIS: INFECTION UNDER THE THUMBNAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POINPOINT LASER NAIL FUNGUS LASER TREATMENT GEX PATHOLASE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R