BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO Z

    MDR report key: 8162968 · Received December 13, 2018

    Report

    Report Number
    3032618-2018-00013
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    August 17, 2018
    Report Date
    December 13, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE X-SHORT ANTI-TIPS SHIPPED WITH THIS CHAIR ARE PART OF A KNOWN POPULATION OF X-SHORT ANTI-TIPS THAT WERE POTENTIALLY NOT MADE TO THE DESIGN SPECIFICATIONS. TISPORT, LLC HAS INITIATED A VOLUNTARY MARKET CORRECTION TO MITIGATE THE RISK OF INJURY TO THE END USER, WHICH IS PENDING FDA APPROVAL AND ASSIGNMENT OF CORRECTION/REMOVAL REPORTING NUMBER UNDER 21 USC 360I(F). THIS VOLUNTARY MARKET CORRECTION IS TRACKED UNDER CPA NO. (B)(4). WE HAVE REACHED OUT TO THE END USER FOR FURTHER INFORMATION, BUT HAVE NOT BEEN PROVIDED ANY INFORMATION ABOUT THE STATUS OF THE ANTI-TIPS, OR ANY FURTHER DETAILS ABOUT THE INCIDENT. IF OUR INVESTIGATION REVEALS ANY ADDITIONAL INFORMATION THAT CHANGES THE NATURE OF THE CONCLUSIONS REACHED IN THIS REPORT, A FOLLOW UP MEDWATCH FORM 3500A WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS HER WHEELCHAIR TIPPED BACKWARDS WITH HER SEATED IN IT, RESULTING IN BI LATERAL SCAPHOID FRACTURES. THE DHR INDICATES THE EXTENSION TUBE WAS AN X-SHORT STANDARD ANTI-TIP. WE HAVE NOT BEEN PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE INCIDENT, OTHER THAN THESE ALLEGATIONS, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000292 AERO Z WHEELCHAIR IOR TISPORT, LLC AERO Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization