FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 3781065 · Received April 30, 2014

Report

Report Number
1531186-2014-01579
Date Received
April 30, 2014
Date of Event
March 6, 2014
Report Date
March 26, 2014
Manufacturer
KENSTONE METAL
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AZ, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

DEALER STATES THE BEARINGS ON FRONT CASTERS CAME APART AND THE END USER WAS NOT INJURED BUT FELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
259780 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

Patients

Seq Age Sex Outcome Treatment
1 38 YR Other