BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLF2800 CLINIFLOAT

    MDR report key: 67610 · Received February 5, 1997

    Report

    Report Number
    1313850-1997-00003
    Event Type
    Injury
    Date Received
    February 5, 1997
    Date of Event
    January 13, 1997
    Report Date
    February 4, 1997
    Manufacturer
    GAYMER INDUSTRIES, INC.
    Product Code
    FOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MALE PT, AGE 72 YRS, WITH MULTIPLE SCLEROSIS, HAVING MULTIPLE STAGE 4 PRESSURE ULCERS, AND SEVERELY CONTRACTED LOWER LIMBS, WAS OBSERVED WITH AN ADDITIONAL INJURY AFTER ONE DAY ON A WATER FLOATATION BED SYSTEM. THE INJURY WAS DESCRIBED AS 1-1/2 DIAMETER BLISTER AND REDDENED AREA ON THE LEFT HIP. THE HOSP PERSONNEL STATED THAT THE BED INDICATED AN OPERATING TEMP OF 89 F. THE PT WAS REMOVED FROM THE BED. THE HOSP CONSIDERS THE INJURY SERIOUS DUE TO THE PT'S CONDITION AND THE SIZE OF THE INJURY. THE CAUSE OF THE INJURY HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLF2800 CLINIFLOAT CLINIFLOAT FLOATATION BED FOH GAYMER INDUSTRIES, INC. CLF2800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other