FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 3955529 · Received July 24, 2014

Report

Report Number
1531186-2014-02745
Date Received
July 24, 2014
Report Date
June 18, 2014
Manufacturer
JIANGSU YUYUE MEDICAL EQUIP.
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

DEALER STATES A WELDMENT TOWARD THE FOOTPLATE HAS COMPLETELY BROKEN OFF. DEALER WANTS ALL FOOTREST REPLACED, DUE TO LIABILITY OF INSTITUTION

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
435285 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX JIANGSU YUYUE MEDICAL EQUIP. 6891

Patients

Seq Age Sex Outcome Treatment
1 Other