BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q700M

    MDR report key: 16039018 · Received December 22, 2022

    Report

    Report Number
    2937137-2022-00015
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 22, 2022
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    PMA / PMN Number
    K172384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCUSSION: IN REVIEWING THE COMPLAINT, THE DEALER REPORTS THAT THE END USER FELL AND "CRACKED" THEIR RIBS. THERE ARE NO DETAILS ON HOW THE END USER FELL, THE SEVERITY OR NUMBER OF THE CRACKED RIBS, THE DEGREE OF ANY BONE BREAK, AND WHETHER THE END USER RECEIVED MEDICAL TREATMENT. THE DEALER ASSUMES THAT THE END USER VISITED THE HOSPITAL OR EMERGENCY ROOM DUE TO THE ALLEGED INJURY, BUT SHE DOES NOT KNOW FOR SURE. THE DEALER MENTIONED WITH RESPECT TO THE END USER'S POWER WHEELCHAIR THAT THE POWER CENTER MOUNT HAS ELEVATED THE LEG AREA AND IS NOT CURRENTLY ABLE TO BE BROUGHT DOWN. SHE STATES THAT AT THIS TIME, SHE IS NOT SURE IF THE USER'S FALL WAS RELATED TO THE LEG AREA OF THE WHEELCHAIR BEING ELEVATED. THERE ARE LIMITED DETAILS ON THE INCIDENT AND THE ALLEGED INJURY IN GENERAL. CONCLUSION: WHILE THERE IS LIMITED INFORMATION ON THE INCIDENT, DUE TO THE ALLEGATION OF A SERIOUS INJURY (CRACKED RIBS PRESUMABLY MEANING A BONE BREAK), THIS MDR IS BEING FILED. SHOULD NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DEALER REPORTS THAT THE END USER FELL AND ALLEGEDLY "CRACKED" HER RIBS (PRESUMABLY MEANING SOME DEGREE OF BONE BREAK). THERE ARE LIMITED DETAILS ON THE INCIDENT AND THE REPORTED INJURY IN GENERAL. THERE IS NO INFORMATION ON THE EXTENT OF THE INJURY OR IF MEDICAL TREATMENT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865146 QUICKIE Q700M POWER WHEELCHAIR ITI SUNRISE MEDICAL (US) LLC Q700M

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other