BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEHIP AIRX

    MDR report key: 3899510 · Received June 26, 2014

    Report

    Report Number
    3006121457-2011-00001
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    September 15, 2011
    Report Date
    June 25, 2014
    Manufacturer
    TYTEX SLOVAKIA S.R.O.
    Product Code
    IQE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE HAD INSUFFICIENT EVIDENCE OBTAINED FROM THE FACILITY WHERE THE INCIDENT OCCURRED TO DETERMINE WHETHER THE DEVICE MAY HAVE CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    THE USER OF THE PRODUCT FELL (SLIPPED FROM A LOW CHAIR) AND SUSTAINED A FRACTURED NECK OF FEMUR (HIP FRACTURE) WHILST THE PRODUCT WAS INSITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374722 SAFEHIP AIRX HIP PROTECTOR IQE TYTEX SLOVAKIA S.R.O. 336650-05.01.F62 174310

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization