FDA Adverse Event Malfunction Summary report: N

SOLARA 3G LTD 20W 24 COM 9153653250

MDR report key: 5543656 · Received April 4, 2016

Report

Report Number
1525712-2016-00932
Event Type
Malfunction
Date Received
April 4, 2016
Report Date
March 30, 2016
Manufacturer
INVACARE TAYLOR STREET
Product Code
IOR
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

USER'S MOTHER REPORTED THAT THE BAR AT THE BOTTOM OF THE CHAIR HAS SNAPPED. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

USERS MOTHER REPORTED THAT THE BAR AT THE BOTTOM OF THE CHAIR HAS SNAPPED. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
200270 SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA 3G

Patients

Seq Age Sex Outcome Treatment
1