BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPH CHECK II PILLOW

    MDR report key: 116095 · Received August 28, 1997

    Report

    Report Number
    MW1011965
    Event Type
    Malfunction
    Date Received
    August 28, 1997
    Date of Event
    August 5, 1997
    Report Date
    August 26, 1997
    Manufacturer
    HERCULITE PRODUCTS, INC.
    Product Code
    KME
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP USED A PILLOW, AFTER PILLOW WAS SANITIZED, HOSP EMPLOYEE LOOKED INSIDE PILLOW & FOUND AN AREA THAT HAD BEEN CONTAMINATED WITH A BODILY FLUID & BLOOD. PILLOW SEEMED TO BE ABLE TO LET A FLUID PENETRATE TO INSIDE CONTENTS. WAS NOT KNOWN HOW LONG PILLOW HAD BEEN SATURATED. A PILLOW WAS PUT IN ITS PLACE. A PILLOW CASE WAS USED ON THIS REUSABLE PILLOW FOR EVERY USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAPH CHECK II PILLOW PILLOW KME HERCULITE PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other