BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOUVA III

    MDR report key: 4425601 · Received January 14, 2015

    Report

    Report Number
    1521608-2014-00001
    Event Type
    Injury
    Date Received
    January 14, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 7, 2014
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    KGL
    PMA / PMN Number
    K041212
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NATIONAL BIOLOGICAL CORPORATION'S FILED SERVICE TECHNICIAN EVALUATED THE PHOTOTHERAPY DEVICE IN QUESTION ON (B)(6) 2014. THE STANDARD NATIONAL BIOLOGICAL CORPORATION INSTALLATION AND SERVICE PROTOCOL WAS FOLLOWED. PER THE FIELD SERVICE TECHNICIAN'S INSTALLATION AND IN-SERVICE SUMMARY REPORT THE "BOOTH IS IN 100% WORKING ORDER. SENSOR AND METER CALIBRATIONS ARE UP TO DATE. LINE/LOAD VOLTAGE IS NORMAL. TIMER PROFILE READING IS ACCURATE. GOGGLES ARE NBC AND ARE 100% UVB BLOCKING PER 500C METER # (B)(4) AND (B)(4) RM. NO INDICATION OF DAMAGE OR DEFECT TO THE GOGGLES". DURING THE NATIONAL BIOLOGICAL CORPORATION COMPLAINT INTAKE PROCESS IT WAS NOTED THAT THE PT STATED THAT THEY DID NOT REMOVE THEIR GOGGLES DURING THE TREATMENT ON (B)(6) 2014. WHEN NATIONAL BIOLOGICAL CORPORATION CONTACTED UCONN DERMATOLOGY ASSOCIATION THE NURSE DISCLOSED THAT IN THE PAST, AND ON SEPARATE OCCASIONS, THE PT HAS REMOVED THE PILLOW CASE AND GOGGLES AND PEEKED DURING TREATMENTS; AND HAS COME OUT OF THE UNIT DURING TREATMENT AND TRIED TO RESTART THE PHOTOTHERAPY DEVICE HERSELF. DUE TO THE FACT THAT THE FIELD SERVICE TECHNICIAN'S REPORT CONCLUDED THAT THE PHOTOTHERAPY DEVICE AND GOGGLES IN QUESTION WERE FOUND TO BE OPERATING WITHIN SPECIFICATIONS NBC BELIEVES THE PT INJURY WAS CLEARLY A RESULT OF MISUSE OF INSTRUCTIONS FOR USE A IT PERTAINS TO EYE PROTECTION.

    Description of Event or Problem · 1

    THE PT RECEIVED TREATMENT ON (B)(6) 2014 FOR APPROXIMATELY 8 MINUTES AND 4 SECONDS AT 2000 MJ. THE PT WAS WEARING NBC PROVIDED GOGGLES (PART # 9PE-004), AS WELL AS A PILLOW CASE OVER HER HEAD. PRIOR TO THE START OF THE TREATMENT THE NURSE INSTRUCTED THE PT TO PUT ON HER GOGGLES. THE PILLOW CASE WAS THEN PLACED OVER HER HEAD. THE NURSE VERIFIED THE PT WAS WEARING HER GOGGLES AND THE PILLOW CASE WHEN THE TREATMENT STARTED BEFORE SHE EXITED THE ROOM. ON (B)(6) 2014 THE PT AWOKE AT 2 AM AND COMPLAINED OF A BURNING SENSATION ON HER EYES. THE PT'S MOTHER TOOK THE PT TO THE EMERGENCY ROOM WHERE THEY REFERRED HER TO A OPHTHALMOLOGIST. THE PT SAW THE OPHTHALMOLOGIST AND WAS TREATED FOR CORNEAL BURNS. THE PT'S MOTHER CALLED UCONN DERMATOLOGY ASSOCIATION ON (B)(6) 2014 AND STATED THAT THE PT WAS BURNED DURING HER LAST TREATMENT ON (B)(6) 2014. THE PT'S GOGGLES WERE CHECKED AND WERE FOUND TO BE 100% UV BLOCKING AND FREE FROM DAMAGE AND DEFECT. THE PILLOW CASE USED WAS CHECKED AND FOUND TO BE FREE FROM DAMAGE OR DEFECT. THE OUTPUT OF THE PHOTOTHERAPY DEVICE WAS CHECKED AND WAS REPORTED AT 4.13 WHICH FALLS WITHIN THE NORMAL OUTPUT RANGE OF 1.80- 7.40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34877 HOUVA III PHOTOTHERAPY UNIT KGL NATIONAL BIOLOGICAL CORP. UHU-318 6986

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other