BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZY ULTRA 4

    MDR report key: 6902649 · Received September 28, 2017

    Report

    Report Number
    3006459587-2017-00006
    Event Type
    Injury
    Date Received
    September 28, 2017
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED ISSUE SINCE THE 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

    PER END USER, CLAIMS THE FOOTREST HAS A SHARP PART THAT POINTS OUT WHERE THE LEG RESTS OPEN. END USER HAS RECEIVED NUMEROUS LUMPS, BRUISES, AND OPEN WOUNDS DUE TO THIS, SO HAS HER CARE PROVIDERS. SHE ALSO STATES THE CHAIR IS HEAVIER THAN IT SHOULD BE. SHE STATED SHE WILL BE CONTACTING A DEALER IN HER AREA TO REPLACE THIS PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680009 BREEZY ULTRA 4 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC EIB7

    Patients

    Seq Age Sex Outcome Treatment
    1