FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 4040772 · Received August 27, 2014

Report

Report Number
1531186-2014-03565
Date Received
August 27, 2014
Report Date
July 31, 2014
Manufacturer
UNKNOWN
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

DEALER ALLEGED THAT THE LEG SNAPPED DURING USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
521170 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781

Patients

Seq Age Sex Outcome Treatment
1 Other