BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZY EC2000

    MDR report key: 6902586 · Received September 28, 2017

    Report

    Report Number
    3006459587-2017-00005
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE PUSH CANE GRIP COMING OFF SINCE THE CHAIR/ITEM WAS NOT RETURNED FOR EVALUATION. THERE IS ALSO NO RECORD OF ANY REPLACEMENT PARTS REQUESTED FOR THIS CHAIR OR THIS CHAIR EVER BEING SERVICED BY A DEALER. 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

    ON (B)(6) 2015 PER END USER SAYS YESTERDAY, HIS BROTHER IN LAW WAS PUSHING HIM IN WHEELCHAIR DOWN A FLIGHT OF STEPS AND ONE OF THE PUSH CANE GRIPS CAME OFF AND CAUSED HIM TO BE THROWN OUT OF THE CHAIR AND FALL ABOUT 5 FEET DOWN THE STAIRS. HE WAS INJURED IN FALL AND ALLEGEDLY BROKE HIS HIP BONE, PINCHED NERVES, ALONG WITH OTHER BUMPS AND BRUISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679983 BREEZY EC2000 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC 216RADPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R