FDA Adverse Event Summary report: N

MECHANICAL (MANUAL) WHEELCHAIR

MDR report key: 2781839 · Received October 11, 2012

Report

Report Number
1531186-2012-01160
Date Received
October 11, 2012
Date of Event
September 14, 2012
Report Date
October 10, 2012
Manufacturer
JUMAO MEDICAL EQUIPMENT
Product Code
IOR
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

DEALER CALLED STATING THAT WHILE THE END USER WAS RIDING IN THE V18RFR MANUAL WHEELCHAIR, A WHEEL SPOKE HAD ALLEGEDLY BROKE. REPLACEMENT WHEEL HAS BEEN ISSUED. NO INJURY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT V18RFR

Patients

Seq Age Sex Outcome Treatment
1 52 MO Other