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

Model Number F3

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abrasion (1689); Contusion (1787); Bone Fracture(s) (1870)

Event Date 05/27/2017

Event Type  Injury  

Manufacturer Narrative

Investigation pending and root cause for this failure mode cannot be determined.Permobil received reports from an attorney representing a music venue in (b)(6) regarding an active lawsuit involving an incident with an end user in a permobil wheelchair.This second-hand complaint indicates the user was not wearing a positioning belt and fell from the wheelchair while on a portable ramp.This incident occurred in (b)(6) 2017 and went unreported to permobil/servicing dealer until now.The patient nor the patient's attorney has made contact with permobil to involve us in this matter.The patient's contact information is also unknown and due to insufficient information being available at this time.This investigation will remain open.If additional information is received that will further our investigation, a follow-up report will be sent and contain any missing information not within this report.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

Reports are the patient was attending a concert at the knitting factory in (b)(4) and attempted to negotiate two or three 6-inch steps with a portable ramp.Witnesses state that the patient first reclined the seating system backwards as far as possible before going down the ramp.End user is reported to not be wearing a positional belt and she fell out of the wheelchair when it came to a stop.The patient is reported to have sustained fracture through the inferior aspect of the anterior tibial tubercle with a possible fracture of the fibula, and a non-displaced fracture of the left big toe, and multiple contusions and abrasions.The client is suing the knitting factory blaming the facility for her being thrown from her wheelchair.

• Brand Name: PERMOBIL F3
• 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: shawn waynick ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 8264447
• MDR Text Key: 133712040
• Report Number: 1221084-2019-00004
• Device Sequence Number: 1
• Product Code: ITI
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 77