BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE PULSE

    MDR report key: 6902088 · Received September 28, 2017

    Report

    Report Number
    2937137-2017-00028
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    November 4, 2015
    Report Date
    November 4, 2015
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    UDI-DI
    05022408051977
    PMA / PMN Number
    K142457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER ALSO STATED THAT DEALER, (B)(4) HAS TOLD HER THAT THE TIRES HAVE BEEN EXAMINED BY QUALITY (NOT SURE IF THEY MEAN SUNRISE MEDICAL QUALITY OR THEIR OWN) AND THEY DIDN'T SEE ANY MANUFACTURER'S DEFECTS, SO ALL HER PREVIOUS ORDERS FOR CASTERS HAVE BEEN CHARGED AND NOT COVERED UNDER WARRANTY. SUNRISE MEDICAL CHECKED THE SERIAL NUMBER HISTORY AND FOUND ONLY 2 ORDERS FOR CASTERS BUT NO RETURN AUTHORIZATION NUMBERS FOR WARRANTY ISSUES REGARDING THE CASTERS. THEREFORE PARTS WERE NOT RETURNED AND SUNRISE MEDICAL WAS UNABLE TO PERFORM AN EVALUATION. THIS COMPLAINT FOR THE ALLEGED INJURIES WAS CALLED IN ON (B)(6) 2015 AND THE INJURIES WERE NEVER CONFIRMED. THE ORIGINAL COMPLAINT, HOWEVER, THAT WAS CALLED IN ON (B)(6) 2015 WAS TO ADVISE SUNRISE MEDICAL THAT SHE (END USER) PREFERRED THE SOLID TIRES AND NOT THE PNEUMATIC/AIR FILLED TIRES. 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 END USER STATED THE ISSUE WITH TIRES SLIDING OFF, WHAT SHE DESCRIBES AS "THE METAL PART OF CASTERS" HAVE NOW CAUSED HER TO GET INJURED TWICE. THE FIRST TIME WAS IN EARLY (B)(6) , SHE WAS SLOWLY GOING DOWN RAMP IN HER HOUSE AND THE TIRES BEGAN TO SLIDE OFF THE FORK AND SHE WAS JERKED AND THROWN OFF HER CHAIR. SHE WENT TO THE HOSPITAL AND GOT X-RAYS. ALLEGEDLY SHE WAS TOLD HER NOSE WAS BROKEN IN 2 PLACES AND SHE HAD 2 BLACK EYES. WHEN IT HAPPENED AGAIN LAST WEEK SHE WAS GOING UP THE RAMP OUTSIDE OF HER HOUSE, WHEN THE TIRES STARTED SLIDING OFF THE METAL FORK AGAIN. HER SEAT BELT SNAPPED AND SHE WAS THROWN FROM CHAIR. SHE WENT TO THE HOSPITAL WITH AN ALLEGED CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679680 QUICKIE PULSE WHEELCHAIR POWERED ITI SUNRISE MEDICAL (US) LLC EIPW22 05022408051977

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R