BEUDAMED
    FDA Adverse Event Summary report: N

    COMFORT RINSE-FREE SHAMPOO CAP

    MDR report key: 2263438 · Received September 12, 2011

    Report

    Report Number
    2263438
    Date Received
    September 12, 2011
    Date of Event
    September 11, 2011
    Report Date
    September 12, 2011
    Manufacturer
    SAGE PRODUCTS INC.
    Product Code
    FYF
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    UNRESPONSIVE, VENTILATED PATIENT SUSTAINED A SECOND DEGREE BURN TO FOREHEAD AND NAPE OF NECK FOLLOWING USE OF NO-RINSE SHOWER CAP. RN HEATED PRODUCT ACCORDING TO MANUFACTURER'S AND PRODUCT PACKAGE INSTRUCTIONS. BURN NOTED AFTER CAP WAS REMOVED AFTER APPROXIMATELY FIVE MINUTES. PHYSICIAN MADE AWARE AND ORDERED SILVADENE TO AFFECTED AREAS AND CONSULTED WOUND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT RINSE-FREE SHAMPOO CAP CAP, SURGICAL FYF SAGE PRODUCTS INC. 7909 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NO OTHER THERAPIES