FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 2962747 · Received February 14, 2013

Report

Report Number
1531186-2013-00598
Date Received
February 14, 2013
Report Date
February 14, 2013
Manufacturer
KENSTONE METAL
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER THE SEAT IS CRACKED ON COMMODE. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
65442 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

Patients

Seq Age Sex Outcome Treatment
1 Other