FDA Adverse Event Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 3103509 · Received May 9, 2013

Report

Report Number
1531186-2013-01984
Date Received
May 9, 2013
Report Date
April 15, 2013
Manufacturer
PINGHU WEIFENG MATERIAL TECHNOLOGY
Product Code
IKX
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

POTENTIAL FOR INJURY ASSOCIATED WITH THE SUCTION CUPS COMING OFF THE MODEL 98071 SHOWER CHAIR. THIS EVENT COULD LEAD TO PRODUCT INSTABILITY AND SLIPPING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
202889 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 98071

Patients

Seq Age Sex Outcome Treatment
1 Other