BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QM710

    MDR report key: 7393893 · Received April 3, 2018

    Report

    Report Number
    2937137-2018-00003
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    June 5, 2015
    Report Date
    March 11, 2018
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    UDI-DI
    05022408052363
    PMA / PMN Number
    K083249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL'S LEGAL TEAM IS CURRENTLY INVESTIGATING THIS CLAIM. INVESTIGATION INTO THIS ALLEGATION SHOWS THAT A REPLACEMENT SUSPENSION SPRING KIT WAS REQUESTED ON 6/8/2015. ASSOCIATED SERVICE RECORD (DATED (B)(6) 2015) REPORTS THAT THE GAS STRUTS WERE REPLACED. REPLACEMENT GAS STRUTS WERE REQUESTED BY NATIONAL SEATING AND MOBILITY ON 6/8/2015. NO REPORT OF INJURY WAS MADE AT THAT TIME OR SUBSEQUENT TO THAT TIME. THERE WERE NO OTHER SERVICE-RELATED PARTS ORDERS, SERVICE REQUESTS, OR COMPLAINTS REPORTED BETWEEN 6/5/2015 AND (B)(6) 2018 (THE DATE OF RECEIPT OF CLAIMANT'S CASE (B)(4)). SUNRISE HAS NOT BEEN ABLE TO DETERMINE THE ROOT CAUSE SINCE THIS INCIDENT AND ALLEGED INJURIES HAVE NEVER BEEN REPORTED TO SUNRISE MEDICAL (US) LLC. AN EMAIL COMMUNICATION RECEIVED ON (B)(6) 2018 FROM (B)(6) OF (B)(6) INCLUDED AN ATTACHMENT OF AN AMENDED COMPLAINT, CASE (B)(4), WHEREBY THE CLAIMANT ((B)(6)) FILED A CLAIM OF INJURY AGAINST (B)(6). THIS IS THE FIRST CLAIM OF ALLEGED INJURIES RECEIVED BY SUNRISE MEDICAL (US) LLC AND DOES NOT DETAIL WHAT INJURIES MAY HAVE OCCURRED. THEREFORE, ROOT CAUSE ANALYSIS CANNOT BE PERFORMED AT THIS TIME UNTIL ADDITIONAL DETAILS ARE PROVIDED BY CLAIMANT.

    Description of Event or Problem · 1

    ON 3/11/2018 SUNRISE MEDICAL (US) LLC RECEIVED NOTIFICATION FROM DEALER, (B)(6), THAT HIS PATIENT ((B)(6)) HAS FILED A LAWSUIT FOR INJURIES. THE AMENDED COMPLAINT STATES (IN PARAGRAPH 7) "A DEFECTIVE SEATBELT AND FRONT WHEELS THAT DO NOT TOUCH THE GROUND, CAUSING THE PLAINTIFF TO BE INJURED." PARAGRAPH NO. 8 IN THE AMENDED COMPLAINT STATES THAT "PLAINTIFF, (B)(6), SUFFERED INJURIES AND DAMAGES OF A PERSONAL, PECUNIARY AND PERMANENT NATURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237154 QUICKIE QM710 WHEELCHAIR, POWERED ITI SUNRISE MEDICAL (US) LLC EIPW11 05022408052363

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability