BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK PARAFORM PROCESSING/EMBEDDING MEDIUM FORMULA3 PARAFFIN

    MDR report key: 3820196 · Received April 22, 2014

    Report

    Report Number
    2083544-2014-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 22, 2014
    Manufacturer
    SAKURA FINETEK U.S.A., INC.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    SAKURA RECEIVED A TOTAL OF (4) COMPLAINTS THAT TISSUE-TEK PARAFORM PROCESSING/EMBEDDING MEDIUM FORMULA2 PARAFFIN. PRODUCT CODE 7052, LOT # 263922, DOES NOT MET ALL ITS LABELED CLAIM OF 56-58 DEGREES C. ONE (2) SITE EXPERIENCED DIFFICULTY IN STAINING. SAKURA'S COMPARISON STUDY REVEALED THAT LOT# 263922 HAS VARIATIONS IN MELTING TEMPERATURE. IT WAS OBSERVED THAT SOME PARAFFIN MELTED AT THE RANGE OF 55-65 DEGREES CENTIGRADE VERSUS THE SPECIFIED RANGE OF 56-58 DEGREES CENTIGRADE. USING THE LOT 263922 MAY POTENTIALLY RESULT IN THE FOLLOWING SITUATIONS: CLOUDY APPEARANCE OF THE MELTED PARAFFIN AT TEMPERATURE BELOW 65 DEGREES CENTIGRADE; BLOCKS MAY HAVE A DIFFERENT MILKY, VISUAL APPEARANCE; CUT SECTIONS MAY REQUIRE A HIGHER WATER BATH TEMPERATURE TO STRETCH PROPERLY, AND/OR IMMUNOHISTOCHEMISTRY AND/OR SPECIAL STAINING MAY BE COMPROMISED DUE TO INCOMPLETE DEWAXING DEPARAFFINIZATION. A PROLONGED DEWAXING DEPARAFFINIZATION PROCEDURE MAY BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244065 TISSUE-TEK PARAFORM PROCESSING/EMBEDDING MEDIUM FORMULA3 PARAFFIN PARAFFIN IEO SAKURA FINETEK U.S.A., INC. 263922

    Patients

    Seq Age Sex Outcome Treatment
    1