FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 3020235 · Received March 25, 2013

Report

Report Number
1531186-2013-01275
Date Received
March 25, 2013
Report Date
February 28, 2013
Manufacturer
C.T.M. HOMECARE PRODUCT, INC
Product Code
INI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES BRAKE IS NOT WORKING. NO SERIAL NUMBER PROVIDED. PART NUMBER, (B)(4), IS FOR EITHER A LYNX 3 OR 4 TRANSAXLE. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
122053 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 Other