BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1943513 · Received November 8, 2010

    Report

    Report Number
    3004468271-2010-00036
    Event Type
    Other
    Date Received
    November 8, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CARER WAS REMOVING THE SARA 3000 BATTERY FROM THE CHARGER AND WENT TO PLACE ON A HOIST WHEN BATTERY ACID LEAKED FROM THE BATTERY ONTO HER LEG AND ANKLE. THE CARER WAS WEARING STOCKINGS AT THE TIME AND THE ACID BURNED THROUGH THE STOCKING ONTO HER SKIN. THE CARER WASHED HER SKIN IMMEDIATELY; THERE WAS A SLIGHT REDNESS TO THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV HEA0003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other