BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 6901565 · Received September 28, 2017

    Report

    Report Number
    2937137-2017-00027
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL DOCUMENTATION IS AVAILABLE FOR THIS CASE. THIS CHAIR HOWEVER, WAS AFFECTED BY THE Q7 BACKREST BRACKET RECALL INITIATED BY SUNRISE MEDICAL ON 7/5/2016 AND ADDRESSED IN CAPA (B)(4). ALTHOUGH THIS COMPLAINT IS FOR THE SCREWS AND NOT THE BACKREST BRACKETS, ATTEMPTS WERE MADE BY (B)(4) TO LOCATE THIS END USER, HOWEVER UNSUCCESSFUL. SUNRISE MEDICAL IS UNABLE TO DETERMINE WHAT THE ROOT CAUSE FOR THE HARDWARE FAILURE IS SINCE NO PARTS WERE RETURNED FOR EVALUATION AND NO RECORD WAS FOUND OF ANY REPAIRS DONE TO THE CHAIR. THIS ELECTRONIC MDR IS BEING SUBMITTED TO FDA FOLLOWING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY SUNRISE MEDICAL, INC. AS PART OF A CORRECTIVE AND PREVENTIVE ACTION DISCUSSED WITH FDA IN RESPONSE TO AN INSPECTIONAL OBSERVATION. THE REVIEW REQUIRED A DOCUMENTED REASSESSMENT OF EACH COMPLAINT FOR REPORTABILITY UNDER 21 CFR PART 803. AS A RESULT OF THE ASSESSMENT, THIS EVENT WAS IDENTIFIED AS MEETING THE REGULATORY REPORTING CRITERIA IN THE COMPANY'S CURRENT MDR PROCEDURE, AND IS BEING SUBMITTED TO FDA OUT OF AN ABUNDANCE OF CAUTION AND COMPLIANCE TO AID IN PROVIDING FDA WITH UP-TO-DATE INFORMATION.

    Description of Event or Problem · 1

    PER (B)(6) FROM OUR LEGAL DEPARTMENT, STATES END USER ALLEGES THE SCREWS THAT HOLD THE BACKREST ON THE CHAIR FAILED CAUSING INJURY TO HIS HEAD AND SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680884 QUICKIE Q7 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening