FDA Adverse Event Malfunction Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 4213540 · Received October 30, 2014

Report

Report Number
1525712-2014-07401
Event Type
Malfunction
Date Received
October 30, 2014
Report Date
October 7, 2014
Manufacturer
UNKNOWN
Product Code
ILS
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

END USER ADVISED SEAT IS NOT STAYING IN ONE PLACE AND BACK IS LOOSE ON COMMODE. END USER COULD NOT PROVIDE MODEL NUMBER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
694956 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS UNKNOWN SELFCARE

Patients

Seq Age Sex Outcome Treatment
1 Other