FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 2864071 · Received December 10, 2012

Report

Report Number
1531186-2012-01694
Date Received
December 10, 2012
Report Date
December 7, 2012
Manufacturer
C.T.M. HOMECARE PRODUCT, INC
Product Code
INI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
LA, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

DEALER STATES THE TRANSAXLE IS MAKING A CLUNKING NOISE AND BAD BEARINGS.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 Other