MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5; POWERED WHEELCHAIR

Model Number	F5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dealer reports as end-user was driving device, they reportedly hit a bump which allegedly caused the end-users right foot to fall off the footplate and fall to the side.It was reported it happened so quickly that their foot got caught underneath the tire and subsequently broke their right leg.Dealer reports the device did not malfunction and is fully operational, but speculates the original service provider should have taken into consideration the need to have some sort of restraint installed to keep the end-users extremities secured.Dealer was provided a quote for various component options to keep the end-users positioned correctly to mitigate recurrence.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report that while end-user was driving the device, they hit a bump in the terrain which caused their right foot to come off the footplate.When this occurred, it was reported the end-users foot rolled under the right drive wheel causing them to suffer a fracture to their right tibia.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 7472467
• Report Number: 1221084-2018-00028
• Device Sequence Number: 11025973
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 41