BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO T

    MDR report key: 6448600 · Received March 30, 2017

    Report

    Report Number
    3032618-2017-00001
    Event Type
    Injury
    Date Received
    March 30, 2017
    Report Date
    March 30, 2017
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER RECEIVED TREATMENT FOR THE WOUND AND REPORTED THAT IT WAS HEALING WELL. THE DHR FOR THIS CHAIR SHOWS THAT IT WAS CONFIGURED CORRECTLY ACCORDING TO THE ORDER SUMMARY. THE DOCUMENTATION AND SPECIFICATIONS FOR THE CHAIR WERE APPROPRIATELY DISSEMINATED TO THE HEALTH SPECIALIST WORKING WITH THE END USER. UPON RECEIPT, THE HEALTH SPECIALIST REVIEWED SIDEWAYS STABILITY WITH THE END USER THROUGH STANDARD CHECKS. IN ADDITION, THE END USER WAS PROVIDED A USER MANUAL THAT WARNS ABOUT ONES CENTER OF GRAVITY AND HOW IT RELATES TO STABILITY AND BALANCE, FACTORS THAT CAN INCREASE THE RISK OF TIP-OVERS, AND PROCEDURES TO FOLLOW TO REDUCE THE RISK. FOR EXAMPLE, THE USER MANUAL STATES: WHEN YOU BEND, REACH OR LEAN FROM YOUR CHAIR YOU WILL AFFECT THE CENTER OF BALANCE OF YOUR CHAIR. THEREFORE, BENDING, REACHING OR LEANING MAY CAUSE YOU TO FALL OR TIP OVER. IN ORDER TO AVOID FALLING OR TIPPING OVER, YOU MUST DETERMINE YOUR PARTICULAR SAFETY LIMITATIONS GIVEN THE CONFIGURATION OF YOUR CHAIR AND YOUR BODY WEIGHT AND TYPE. TO DO THIS, PRACTICE BENDING, REACHING AND LEANING ACTIVITIES (AND VARIOUS COMBINATIONS OF SUCH ACTIVITIES) UNDER THE SUPERVISION OF YOUR HEALTH CARE ADVISOR. DO THIS BEFORE ATTEMPTING ACTIVE USE OF YOUR CHAIR. THE USER MANUAL ALSO STATES: WHEN BENDING OR LEANING, ALWAYS GRASP ONE REAR WHEEL WITH ONE HAND. THIS WILL HELP TO PREVENT A FALL IF THE CHAIR STARTS TO TIP OVER. DEVICE EVALUATED BY MFR: USER MISUSE.

    Description of Event or Problem · 1

    THE END USER CLAIMS THAT WHEN HE WAS REACHING FOR AN OBJECT ON THE GROUND, THE WHEELCHAIR FLIPPED OVER SIDEWAYS RESULTING IN DAMAGE TO THE EPIDERMIS AROUND HIS BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227478 AERO T WHEELCHAIR IOR TISPORT, LLC AERO T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention