FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 2884440 · Received December 22, 2012

Report

Report Number
1531186-2012-01848
Date Received
December 22, 2012
Report Date
December 21, 2012
Manufacturer
C.T.M. HOMECARE PRODUCT, INC
Product Code
INI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE PEGASUS4-S SCOOTER WAS HAVING ISSUES WITH THE PC BOARD. THERE WAS NO PATIENT INJURY REPORTED.

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 PEGASUS4-S

Patients

Seq Age Sex Outcome Treatment
1 Other