BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHAXCELL

    MDR report key: 1936260 · Received December 15, 2010

    Report

    Report Number
    1000381138-2010-00012
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    May 13, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED AT THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    A PT WAS BEING NURSED ON AN ENTERPRISE 5000 HOSPITAL BED WITH BED RAILS IN SITU. AN ALPHAXCELL MATTRESS WAS IN USE ON TOP OF A STANDARD FOAM MATTRESS. IT WAS REPORTED THAT THE BED RAILS WERE INSUFFICIENT AND DID NOT PREVENT THE PT FROM ROLLING OUT OF BED. THE PT SUFFERED A FRACTURED NECK OF THE FEMUR WHICH REQUIRED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHAXCELL ALPHAXCELL FNM ARJOHUNTLEIGH IC087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R