BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2862763 · Received December 10, 2012

    Report

    Report Number
    1531186-2012-01677
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ANI [ A&I ] GROUP TAIWAN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CALLED (B)(6), IN WHICH SHE STATED THAT SHE RECEIVED A CALL ON (B)(6) 2012 FROM END USER. (B)(6) ALLEGES THAT THE END USER STATED HE WAS IN HIS CHAIR, WENT DOWN THE RAMP AT HIS RESIDENCE AND FELL OVER WITH THE CHAIR. SHE STATED THE END USER DID NOT HAVE ANY SERIOUS INJURIES, ONLY SCRATCHES. (B)(6) ALLEGES THE END USER DID NOT SEEK MEDICAL ATTENTION. SHE SENT TECHNICIAN TO PATIENTS RESIDENCE IN WHICH TECHNICIAN ALLEGES THAT END USERS' RAMP IS TOO STEEP AND BECAUSE OF THE MOMENTUM OF GOING DOWN RAMP THIS CAUSED THE CASTORS TO ROTATE. (B)(6) STATED THE TECHNICIAN ADVISED END USER TO REPLACE RAMP. (B)(4).

    Description of Event or Problem · 1

    PROVIDER STATES FRONT CASTER ROTATED IN THE FRAME MOUNT WHILE USER WAS DRIVING CHAIR, CAUSING HIM TO FALL FROM CHAIR. REPORTER ALLEGES END USER WAS IN HIS CHAIR WENT DOWN THE RAMP AT HIS HOME AND FELL WITH THE CHAIR. NO INJURY, BUT SCRATCHES, AND DID NOT SEEK MEDICAL ATTENTION. THE TECHNICIAN ALLEGES THAT END USER'S RAMP IS TOO STEEP AND BECAUSE OF THE MOMENTUM OF GOING DOWN RAMP, THIS CAUSED THE CASTORS TO ROTATE. (B)(6) STATED THE TECHNICIAN ADVISED END USER TO REPLACE RAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI ANI [ A&I ] GROUP TAIWAN IN88AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other