BEUDAMED
    FDA Adverse Event Death Summary report: N

    CALYPOSO

    MDR report key: 4113814 · Received August 21, 2014

    Report

    Report Number
    3007420694-2014-00084
    Event Type
    Death
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION. IMPORTER REF #(B)(4).

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE RESIDENT'S TRANSFER FROM THE BATH TUB THE RESIDENT FELL FROM THE SEAT SIDEWARDS AS NO SAFETY BELT WAS USED. THE RESIDENT INVOLVED IN THE INCIDENT RECEIVED RIBS FRACTURES AND ONE RIB PUNCTURED THE LUNG. THE RESIDENT WAS TAKEN TO THE HOSP. ARJOHUNTLEIGH WAS INFORMED THAT THE RESIDENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506090 CALYPOSO FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. 218100-06

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death