BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN, INC.

    MDR report key: 359073 · Received October 31, 2001

    Report

    Report Number
    MW1023263
    Event Type
    Malfunction
    Date Received
    October 31, 2001
    Report Date
    October 31, 2001
    Manufacturer
    *
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AUTOCLAVE TUBING FROM HENRY SCHEIN, INC, PRODUCT #101-2223, OFTEN BURSTS AND DEVELOPS HOLES DURING NORMAL AUTOCLAVING. THIS HAS OCCURRED FOR ABOUT 6 MONTHS. THE SIMILAR PRODUCT FROM MOORE MEDICAL, INC, DOES NOT EXHIBIT THESE PROBLEMS. RPTR HAS NOTIFIED THEIR HENRY SCHEIN, INC REP. BUT HAVE NOT RECEIVED AN OFFICIAL REPLY ABOUT THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48764 HENRY SCHEIN, INC. AUTOCLAVE TUBING FLE * * NONE LISTED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other