BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE-PRESS

    MDR report key: 3763941 · Received April 18, 2014

    Report

    Report Number
    MW5035739
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Product Code
    IME
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, MY WIFE BOUGHT A PACK OF "EYE-PRESS" FROM THE (B)(6) STORE IN (B)(6) PER HER EYE DOCTOR'S RECOMMENDATIONS. THAT EVENING SHE APPLIED THEM TO HER EYE AS DIRECTED BY THE PACKAGE. ALSO, AS DIRECTED BY THE PACKAGE, SHE PUT THE USED PRESSES IN A BOWL OF WATER AND PLACED THEM IN A MICROWAVE FOR THE REQUIRED 4:00 MINUTES. AT THE END OF THE FOUR MINUTES, SHE FOUND THE PRESSES HAD BURST AND WERE LEAKING THE BLUE FLUID. SHE DISCARDED THEM AND THE NEXT DAY TRIED A NEW SET. (WE LATER RECOVERED THEM FROM THE TRASH) AFTER SHE USED THEM, I PLACED THEM INTO A MICROWAVE FOR 3:00 MINUTES, ONE MINUTE LESS THAN THE INSTRUCTIONS CALL FOR, TO SEE IF THAT WOULD WORK BETTER. THE PRESSED DID NOT BURST THIS TIME BUT WHEN MY WIFE REUSED THEM SHE FOUND THAT THEY BARELY GOT WARM. AFTER THEY WERE COLD I PLACED THE USED EYE-PRESSES INTO A BOWL OF WATER AND MICROWAVED THEM FOR 4:00 MINUTES AS REQUIRED BY THE INSTRUCTIONS. WHEN THE 4:00 MINUTES WERE UP, I NOTED THAT ONE OF THE PRESSES HAD BURST AND WAS ABOUT HALF WAY OUT OF THE SIDE OF THE BOWL OF WATER: THE OTHER PRESS WAS LYING AT THE BOTTOM OF THE BOWL. AS I WAS REMOVING THE BOWL OF VERY HOT WATER, IT APPEARED THAT THE EYE-PRESS AT THE BOTTOM OF THE BOWL BURST CAUSING BOILING HOT WATER TO SPLATTER OUT HITTING MY LEFT HAND AND WRIST. I JERKED VIOLENTLY SPILLING THE BOILING WATER ON MY OTHER WRIST AND DOWN MY FRONT. I SCREAMED IN PAIN AND WITH MY WIFE'S HELP MANAGED TO STRIP OFF ALL MY CLOTHES AND GOT INTO THE SHOWER TO SPRAY COLD WATER OVER THE SCALDED AREAS. I THEN APPLIED ICE TO THE BURNED SKIN. I TRIED TO TOUGH IT OUT BUT THE NEXT DAY I HAD TO GO TO THE DOCTOR AS THE BLISTERS ON MY STOMACH HAD BURST AND WERE WEEPING. THIS IS A DANGEROUS PRODUCT AND SHOULD BE REMOVED FROM USE. DOCUMENT NUMBER (B)(4). MFR NAME AND ADDRESS: OCUGIENE, INC., (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236950 EYE-PRESS EYE-PRESS IME EYE-PRESS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention