BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILITE AERO Z

    MDR report key: 19265156 · Received May 7, 2024

    Report

    Report Number
    3032618-2024-00003
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 1, 2023
    Report Date
    April 8, 2025
    Manufacturer
    PERMOBIL
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, TILITE IS UNABLE TO CONFIRM A PRODUCT MALFUNCTION HAS OCCURRED, AS THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR INSPECTION, NOR ANY PRODUCT RETURNED. AT THIS TIME TILITE IS UNABLE TO REACH A DETERMINATION AS TO CAUSE OF THIS REPORTED EVENT WITHOUT SPECULATION. MORE INFORMATION WAS RECEIVED. THE CUSTOMER REPORTS NO PERMANENT DAMAGE AND TREATED THE INJURY AT HOME. THIS IS A FOLLOW UP REPORT FOR AWARENESS.

    Additional Manufacturer Narrative · 0

    AT THIS TIME, TILITE IS UNABLE TO CONFIRM A PRODUCT MALFUNCTION HAS OCCURRED, AS THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR INSPECTION, NOR ANY PRODUCT RETURNED. THE END-USER IS NOT BEING FORTHCOMING AS TO THE EXTENT OF THE INJURY, OR IF ANY MEDICAL INTERVENTION WAS SOUGHT. AT THIS TIME TILITE IS UNABLE TO REACH A DETERMINATION AS TO CAUSE OF THIS REPORTED EVENT WITHOUT SPECULATION. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINS BACKREST HINGED FAILED, CAUSING A FALL AND SUBSEQUENT HEAD INJURY. EXTENT OF INJURY UNKNOWN. TREATMENT FOR INJURY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141182 TILITE AERO Z MANUAL WHEELCHAIR IOR PERMOBIL N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other