BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II SURGICAL FACE MASK

    MDR report key: 59403 · Received December 26, 1996

    Report

    Report Number
    1625443-1996-00003
    Event Type
    Malfunction
    Date Received
    December 26, 1996
    Date of Event
    November 27, 1996
    Report Date
    December 20, 1996
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED BLOOD STRIKE THROUGH FACE MASK DURING AN OPERATIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TOUCH II SURGICAL FACE MASK SURGICAL APPAREL FXX TECNOL MEDICAL PRODUCTS, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other