BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO T

    MDR report key: 11638810 · Received April 8, 2021

    Report

    Report Number
    3032618-2021-00002
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Report Date
    April 5, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT #MW5099250 WAS RECEIVED. THE REPORTER CLAIMS THAT THE CAMBER PLUG DISASSEMBLED FROM THEIR AERO T MODEL CHAIR CAUSING THE REAR WHEEL TO COME OFF RESULTING IN FALLS. THERE WAS NO INDICATION OF SERIOUS INJURY OR REQUIREMENT FOR MEDICAL INTERVENTION. A SERIAL NUMBER WAS NOT PROVIDED FOR THE CHAIR. WITH THE LIMITED INFORMATION AVAILABLE, WE WERE UNABLE TO IDENTIFY AN INDIVIDUAL CHAIR OR A PRODUCTION TIMEFRAME TO INVESTIGATE. CONTACT INFORMATION FOR THE REPORTER WAS PROVIDED. HOWEVER, MULTIPLE ATTEMPTS WERE MADE TO CONTACT THEM WITHOUT SUCCESS. WITHOUT ADDITIONAL INFORMATION THERE IS NO WAY TO IDENTIFY A SPECIFIC CAUSE OF FAILURE. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE CAMBER PLUG DISASSEMBLED FROM THEIR AERO T MODEL CHAIR CAUSING THE REAR WHEEL TO COME OFF RESULTING IN FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533035 AERO T WHEELCHAIR IOR TISPORT, LLC AERO T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other