BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGINE II SOFT ARCH MASK

    MDR report key: 114997 · Received August 21, 1997

    Report

    Report Number
    1625443-1997-00006
    Event Type
    Other
    Date Received
    August 21, 1997
    Report Date
    July 29, 1997
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FXX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    OR STAFF REPORTED A DERMAL ABRASION ACROSS THE CHEEKS OF THE FACE, WHICH BECAME EDEMATOUS THEN SCABBED OVER. STATED THAT SHE WAS UNABLE TO WEAR A MASK (ANY MASK) FOR 2 WEEKS. WAS TREATED WITH CORTIZONE CREAM. RIGHT CHEEK IS CURRENTLY DISCOLORED WITH POSSIBLE SCARRING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other