BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QM710

    MDR report key: 6901178 · Received September 28, 2017

    Report

    Report Number
    2937137-2017-00025
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    April 2, 2015
    Report Date
    April 2, 2015
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    UDI-DI
    05022408052363
    PMA / PMN Number
    K083249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL DOCUMENTATION IS AVAILABLE FOR THIS CASE. SUNRISE MEDICAL IS UNABLE TO DETERMINE WHAT THE ROOT CAUSE OF THIS INCIDENT WAS. THERE WERE NO REPLACEMENT PARTS ORDERED OR REPORTS OF ANY DAMAGED OR DEFECTIVE ITEMS ON THIS CHAIR. A POSSIBILITY FOR THIS ADVERSE EVENT IS THAT THE END USER'S FOOT SLIPPED OFF THE FOOTREST WITHOUT HIS KNOWLEDGE CAUSING THE INJURY. IT WAS ALSO NOT DETERMINED THE SEVERITY OF THE INJURY. IT WAS ONLY STATED THAT MEDICAL ATTENTION WAS RECEIVED. HOWEVER, NOTHING INDICATING THAT THE TYPE OF TREATMENT PROVIDED WAS TO PREVENT PERMANENT DAMAGE, PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. 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

    ACCOUNT MANAGER, (B)(6) CALLED TO ADVISE THAT (B)(6) VA THERAPIST, (B)(6), REPORTED TO HIM THAT THE END USER GOT HIS FOOT TRAPPED BETWEEN THE CENTER MOUNT FOOTREST AND FRONT CASTER WHICH CUT HIS FOOT. HE IS A QUADRIPLEGIC AND DID NOT FEEL THAT HIS FOOT WAS STUCK. HE WENT TO ER TO RECEIVE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681200 QUICKIE QM710 WHEELCHAIR POWERED ITI SUNRISE MEDICAL (US) LLC EIPW11 05022408052363

    Patients

    Seq Age Sex Outcome Treatment
    1