BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO Z

    MDR report key: 12291347 · Received August 6, 2021

    Report

    Report Number
    3032618-2021-00008
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 10, 2019
    Report Date
    August 3, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL BECAME AWARE THAT A USER CLAIMED TO HAVE BEEN INJURED WHILE USING A TILITE WHEELCHAIR. SHE ALLEGES SHE FELL FROM THE WHEELCHAIR AND SUSTAINED INJURIES TO HER HEAD, BRAIN AND OTHER PARTS OF HER BODY. THE SPECIFIC NATURE AND EXTENT OF THE INJURIES ARE UNKNOWN AT THIS TIME. THERE WERE NO DETAILS GIVEN REGARDING THE CAUSE OF FALLING. THE COMPLAINT ALLEGES, THE USER'S "WHEELCHAIR WAS IN AN UNREASONABLY DANGEROUS CONDITION BECAUSE IT WAS DEFECTIVE IN MANUFACTURE AND/OR CONSTRUCTION AT THE TIME OF MANUFACTURE, DISTRIBUTION, AND/OR SUPPLY BY PERMOBIL [...] AND WAS UNABLE TO WITHSTAND ORDINARY AND FORESEEABLE CONDITIONS OF USE." HOWEVER, NO DETAILS WERE GIVEN IDENTIFYING ANY SPECIFIC DEFECT. THE COMPLAINANT DID NOT IDENTIFY A SERIAL NUMBER FOR THE CHAIR IN QUESTION. HOWEVER, OUR RECORDS IDENTIFIED A CHAIR FOR THIS USER. THE DHR FOR THE CHAIR WAS REVIEWED AND THE CHAIR PASSED APPLICABLE QUALITY TEST AND CONFIGURATION REQUIREMENTS. THIS CHAIR WOULD HAVE BEEN IN USE FOR APPROXIMATELY 3 YRS AND 5 MONTHS AT THE TIME OF THE INCIDENT. THE CLAIM ALSO STATES THAT THE CHAIR WAS SERVICED BY A DEALER PRIOR TO THE INCIDENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WITH THE LIMITED INFORMATION AVAILABLE, THE MANUFACTURER IS UNABLE TO CONFIRM A DEVICE FAILURE OR IDENTIFY A CAUSE OF THE FAILURE. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    A USER ALLEGES THAT THEY FELL FROM THEIR WHEELCHAIR AND HIT THEIR HEAD, RECIEVING INJURIES TO THEIR BRAIN, HEAD AND OTHER PARTS OF THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188374 AERO Z MANUAL WHEELCHAIR IOR TISPORT, LLC AERO Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention