DAILY ACTIVITY ASSIST DEVICES-UTENSIL FOR DRESSING, GROOMING, RECREAT
Received Apr 16, 2010 · Event occurred Feb 22, 2010
Report 1525712-2010-00050 · MDR key 1662394
Product problems
- Bent
Patient
Not reported
- Concussion
Narrative
Description of Event or Problem
THE FACILITY STATES THERE WERE TWO EMPLOYEES ASSISTING THE CONSUMER. THE CONSUMER WAS HOLDING THE TRAPEZE BAR AND PULLING DOWN WHEN THE VERTICAL BAR ALLEGEDLY BENT, CAUSING THE DEVICE TO BEND FORWARD AND HIT THE EMPLOYEE ASSISTANT ON THE HEAD. THIS ALLEGEDLY RESULTED IN A CONCUSSION TO THE EMPLOYEE.
Additional Manufacturer Narrative
A MEDWATCH FORM WAS RECEIVED ON 04/05/2010 (B) (6) PROVIDING ADD'L INFO. NO INJURY TO THE PT HAS OCCURRED. PHOTOS WERE PROVIDED, AND IT IS APPARENT THE TRAPEZE WAS NOT ASSEMBLED PROPERLY. THE FACILITY INDICATES THE DEVICE WAS ASSEMBLED BY THE DISTRIBUTOR WITHIN THIS MEDWATCH FORM. PHOTOS PROVIDED INDICATED THAT THE DEVICE WAS NOT FULLY SEATED IN THE BASE. THE FACILITIES ATTENDANT ALLEGEDLY SUSTAINED AN INJURY. NO MALFUNCTION APPARENT. MDR FILED AS A CONSERVATIVE MEASURE.