MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number F3 CORPUS

Device Problems Mechanical Problem (1384); Structural Problem (2506); Sharp Edges (4013)

Patient Problems Fall (1848); Unspecified Infection (1930); Laceration(s) (1946)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Reporter claims due to the extended time it is taking their provider to service the device, led to events resulting in injuries to the end-user.Reporter claims due to seating components being in an inoperable state, creates difficulty for the end-user while entering/exiting the seating system.This has allegedly led to the end-user having fallen numerous times during their transfers.Reporter also reports the end-user having cut their finger on the plastic portion of the arm rest body, and due to a pre-existing blood disorder, generated an infection which required the amputation of a finger.Investigation determined due to logistical issues; the components required to service the device were not shipped in a timely manner.It is permobil's contention that the reported component failure in and of itself was not the cause of the adverse event, but rather the end-user continuing to use the device in a diminished state leading to their inability to ingress/egress the seating safely.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Received report claiming due to the delays in service activities to repair various seating components, the end-user having difficulty entering and exiting the seating system which has led to the end-user having fallen on multiple occasions leading to injuries requiring medical attention to address.

• Brand Name: PERMOBIL F3 CORPUS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15743985
• MDR Text Key: 303160250
• Report Number: 1221084-2022-00022
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F3 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose