BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRCAST, INC.

    MDR report key: 125363 · Received October 9, 1997

    Report

    Report Number
    2242894-1997-90001
    Event Type
    Injury
    Date Received
    October 9, 1997
    Date of Event
    September 12, 1997
    Manufacturer
    AIRCAST, INC.
    Product Code
    IQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    84 YR. OLD WOMAN WAS FITTED WITH AN AIRCAST PNEUMATIC WALKER. AIRCELLS MAY HAVE BEEN OVERINFLATED. PATIENT LATER DEVELOPED FLUID FILLED BLISTERS. PATIENT APPARENTLY WAS NON COMMUNICATIVE WITH ALZHEIMER'S AND AS A NURSING HOME RESIDENT APPARENTLY DID NOT HAVE THE BENEFIT OF FREQUENT VISUAL CHECKS AS PER INSTRUCTIONS OF THE ORTHOTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRCAST, INC. WALKING BRACE IQP AIRCAST, INC. 01P-S *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention