FDA Adverse Event Malfunction Summary report: N

SOLARA 3G LTD 20W 24 COM 9153653250

MDR report key: 5091223 · Received September 21, 2015

Report

Report Number
1525712-2015-04601
Event Type
Malfunction
Date Received
September 21, 2015
Date of Event
July 30, 2015
Report Date
September 3, 2015
Manufacturer
INVACARE TAYLOR STREET
Product Code
IOR
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SW
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

BROKEN FRAME ON AN AZALEA. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THIS ALLEGED INCIDENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

BROKEN FRAME ON AN AZALEA. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THIS ALLEGED INCIDENT OCCURRED IN (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
623484 SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA3G

Patients

Seq Age Sex Outcome Treatment
1