BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOME-CARE BED

    MDR report key: 279984 · Received May 24, 2000

    Report

    Report Number
    2182305-2000-00011
    Event Type
    Other
    Date Received
    May 24, 2000
    Date of Event
    May 4, 2000
    Report Date
    May 24, 2000
    Manufacturer
    SUNRISE MEDICAL CCG
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED PER THE DEALER HOME USER WHO WAS VERY HEAVY SET WANTED EXTRA BRAKES ON THEIR BED, DEALER WENT TO USER'S HOME AND PUT ON TWO EXTRA CASTER BRAKES (BED NOW HAS FOUR BED CASTER WITH BRAKES). HOME USER WENT TO GET UP FROM THE BED AND THE BED "GOT AWAY FROM USER AND USER FELL TO THE FLOOR. WAS TAKEN TO THE HOSP FOR EXAM NOTHING WAS FOUND, RELEASED AND WENT HOME. PER USER BEFORE FALL USER WAS SCHEDULED FOR SURGERY BECAUSE OF USER'S ARTHRITIS AND WAS RECEIVNG 8 HRS OF CARE, USER SAID USER'S DR SAID FALL AGGRAVATED USER'S ARTHRITIS NOW USER NEEDS 24 HOUR CARE. SURGERY STILL SCHEDLULED PER HOME USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME-CARE BED HOME CARE THERAPEUTIC ADJUSTABLE BED FNL SUNRISE MEDICAL CCG SS2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other