FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 4201927 · Received October 27, 2014

Report

Report Number
1531186-2014-05109
Date Received
October 27, 2014
Date of Event
October 1, 2014
Report Date
October 1, 2014
Manufacturer
PINGHU WEIFENG MATERIAL TECHNOLOGY
Product Code
IKX
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PER END USER, THE SUCTION CUP CAME OFF THE LEG WHEN HE PICKED UP THE TRANSFER BENCH. IT HAD TOO MUCH SUCTION AND THE CUP CAME OFF THE LEG.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
683200 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 98071

Patients

Seq Age Sex Outcome Treatment
1 Other