S35 SCALAMOBLIE

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6), INVACARE IS FILING THIS REPORT BECAUSE THE DEVICE IS ALSO MARKETED AND SOLD IN THE U.S. THE PRODUCT HAS NOT BEEN RETURNED, THEREFORE AN INVESTIGATION HAS NOT BEEN COMPLETED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

Description of Event or Problem

THIS EVENT HAPPENED IN (B)(6). WHILE USING THE S35 SCALAMOBLIE TO TAKE THE END USER DOWNSTAIRS IT SUDDENLY FELL. THE END USER SUFFERED SOME BRUISES, AND HE BROKE HIS NOSE IN TWO PLACES. HE WAS ADMITTED TO THE HOSPITAL FOR TWO DAYS.