BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENOR

    MDR report key: 1842774 · Received August 24, 2010

    Report

    Report Number
    3004468271-2010-00026
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED UPON THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE TRANSFERRING RESIDENT FROM WHEELCHAIR TO BED, RESIDENT SLIPPED THROUGH LEFT HAND SIDE OF THE SLING AND HIT HER HEAD ON THE FLOOR. RESIDENT SUFFERED A HEAD LACERATION AND WAS PUT UNDER OBSERVATION AT THE LOCAL HOSPITAL FOR THE NEXT 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR PASSIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV KHA1010-US

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention