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	Pressure Sore/Ulcer (2326)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil was alerted by service provider of the end-user having acquired decubitus ulcer that was reportedly having been caused by applying a great amount of pressure against a thigh support.The end-user was reported to have been admitted into the hospital due to the formation of a sore on their left thigh.Reports indicate the end-user was confined to bed until the sore could heal, but did not require any surgical intervention to correct.The service provider reported having assessed the device and noted the way the end-user is positioned in the seating, they apply a good portion of their weight against the left thigh support and do not have the ability to shift their weight from against it without assistance.The provider reports the thigh support pad was not damaged in any way to have contributed to the reported injury.In efforts to prevent any further pressure related events, the service provider has repositioned the thigh support and has installed an air bladder insert designed to minimize a direct pressure point by evenly displacing pressure across the entire pad surface.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report claiming end-user having received tissue damage to their left leg, reportedly due to their leg pressing into the thigh support.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon, tn
• MDR Report Key: 10202617
• Report Number: 1221084-2020-00027
• Device Sequence Number: 2613546
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/26/2020
• 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: 96