FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 4090428 · Received September 15, 2014

Report

Report Number
1531186-2014-04120
Date Received
September 15, 2014
Report Date
August 22, 2014
Manufacturer
UNKNOWN
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PER END-USER, STATES THE SUCTION CUP BROKE OFF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
568305 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 98071

Patients

Seq Age Sex Outcome Treatment
1 Other