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	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During an abilities expo, permobil representatives were approached by the end-user's father reporting an event having occurred months prior where the end-user had sustained a fracture to their right tibial plateau.The father proclaimed this allegedly occurred as the end-user was performing a stand function while at their school/day program.The father stated as the end-user was at school, he was not present to witness what may have attributed to the reported injury.The father reports the end-user continued to use the device after the event, but had refrained from utilizing the stand function until they had been cleared by their physician.The father reported the end-user had recently been cleared by the physician to continue the use of standing and has been doing so for the last month with no issues.The device was inspected by permobil personnel and found to be fully operational with no abnormalities or deviations being noted.As the device was found fully functional and the end-user's father reporting the end-user is currently using the stand function with no issues, it remains unclear as to how the end-user sustained their injuries.Permobil is unable to confirm the device deviated in any way to have attributed to this reported event.The dhr was reviewed and the device met specification prior to distribution.
Event or Problem Description
Received report claiming while the end-user was at a school/day program, they initiated a standing sequence.It was reported during this function, the end-user suffered a fracture to their right leg.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 9188715
• Report Number: 1221084-2019-00046
• Device Sequence Number: 2537545
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: 68