FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 3062097 · Received April 16, 2013

Report

Report Number
1531186-2013-01586
Date Received
April 16, 2013
Report Date
March 20, 2013
Manufacturer
C.T.M. HOMECARE PRODUCT, INC
Product Code
INI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

PROVIDE STATES HAS NOT SEEN SCOOTER YET. PROVIDER STATES THE USER SAYS THE RIGHT ARMREST IS BENT, AND WANTS ONE UNDER WARRANTY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
162117 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC LEO-3B

Patients

Seq Age Sex Outcome Treatment
1 Other