BEUDAMED
    FDA Adverse Event Death Summary report: N

    FOLDING COMMODE 9153647607

    MDR report key: 4813149 · Received June 2, 2015

    Report

    Report Number
    1531186-2015-01034
    Event Type
    Death
    Date Received
    June 2, 2015
    Date of Event
    April 4, 2015
    Report Date
    June 22, 2015
    Manufacturer
    LERADO ZHONGSHAN PEACEFUL COVE
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2015 THE ADDITIONAL INFORMATION ADDED FOR THIS FOLLOW UP IS DUE TO THE RETURN EVALUATION. THE RETURN EVALUATION CONFIRMED A STRUCTURAL MALFUNCTION.

    Description of Event or Problem · 1

    CONSUMER STATES HER HUSBAND HAD A STROKE AND WHEN HE CAME HOME FROM THE HOSPITAL, HE NEEDED A COMMODE. CONSUMER STATES THE SECOND TIME HER HUSBAND USED THE TOILET, THE CHAIR COLLAPSED ON HIM. CONSUMER STATES THEY PICKED HIM UP AND PUSHED THE CHAIR BACK TOGETHER. CONSUMER STATES THE NEXT TIME HER HUSBAND USED THE CHAIR, THE SAME SITUATION OCCURRED AND HE FELL AGAIN. CONSUMER STATES THAT THEY FOUND THE HOLES ON THE COMMODE HOLES THAT THE CHAIR CONNECTS INTO WAS NOT HOLDING. CONSUMER STATES THAT THROUGH HOSPICE, THEY SWITCHED OUT THE COMMODES AND THE SECOND COMMODE WORKED MUCH BETTER FOR HIM. CONSUMER STATES THAT WHEN HOSPICE EVALUATED HER HUSBAND THOUGHT HE HAD A CRACKED RIB BUT FOUND IT WAS JUST A TEAR AND PRESCRIBED HIM PAIN MEDICATION. CONSUMER STATES THAT HER HUSBAND LIKELY HAD SOME MORE STROKES AND THEN PASSED AWAY SHORTLY AFTER. CONSUMER STATES THAT HIS DEATH WAS NOT A RESULT FROM THE FALLS BUT SHE IS UPSET THAT HE WAS IN SO MUCH PAIN DURING HIS REMAINING TIME BEFORE HE PASSED AWAY DUE TO THE FALLS.

    Description of Event or Problem · 1

    CONSUMER STATES HER HUSBAND HAND A STROKE AND WHEN HE CAME HOME FROM THE HOSPITAL HE NEEDED A COMMODE. CONSUMER STATES THE SECOND TIME HER HUSBAND USED THE TOILET THE CHAIR COLLAPSED ON HIM. CONSUMER STATES THEY PICKED HIM UP AND PUSHED THE CHAIR BACK TOGETHER. CONSUMER STATES THE NEXT TIME HER HUSBAND USED THE CHAIR THE SAME SITUATION OCCURED AND HE FELL AGAIN. CONSUMER STATES THAT THEY FOUND THE HOLES ON THE COMMODE HOLES THAT THE CHAIR CONNECTS INTO WAS NOT HOLDING. CONSUMER STATES THAT THROUGH HOSPICE THEY SWITCHED OUT THE COMMODES AND THE SECOND COMMODE WORKED MUCH BETTER FOR HIM. CONSUMER STATES THAT WHEN HOSPICE EVALUATED HER HUSBAND THOUGHT HE HAD A CRACKED RIB BUT FOUND IT WAS JUST A TEAR AND PRESCRIBED HIM PAIN MEDICATION. CONSUMER STATES THAT HER HUSBAND LIKELY HAD SOME MORE STROKES AND THEN PASSED AWAY SHORTLY AFTER. CONSUMER STATES THAT HIS DEATH WAS NOT A RESULT FROM THE FALLS BUT SHE IS UPSET THAT HE WAS IN SO MUCH PAIN DURING HIS REMAINING TIME BEFORE HE PASSED AWAY DUE TO THE FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355641 FOLDING COMMODE 9153647607 ADAPTOR, HYGIENE ILS LERADO ZHONGSHAN PEACEFUL COVE 9830-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Death