BEUDAMED
    FDA Adverse Event Other Summary report: N

    WAFFLE

    MDR report key: 590519 · Received April 1, 2005

    Report

    Report Number
    590519
    Event Type
    Other
    Date Received
    April 1, 2005
    Date of Event
    March 3, 2005
    Report Date
    April 1, 2005
    Manufacturer
    EHOB, INC
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMALL DARKENED RED AREA NOTED ON BUTTOCKS BY WOUND CARE NURSE DURING DAILY ASSESSMENT. PATIENT HAD BEEN ON A WAFFLE MATTRESS THAT WAS REMOVED FROM BED AS WOULD NOT STAY INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAFFLE AIR MATTRESS IKY EHOB, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR