FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 3020227 · Received March 25, 2013

Report

Report Number
1531186-2013-01265
Date Received
March 25, 2013
Report Date
February 27, 2013
Manufacturer
UNKNOWN
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
WA, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. END USER STATES THE BACK LEG EXTENDED OUT AND SHE HAD TO FORCE THE LEG BACK INTO PLACE. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
122698 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 91-2

Patients

Seq Age Sex Outcome Treatment
1 Other