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

Model Number F3

Device Problems Mechanical Problem (1384); Device Operational Issue (2914)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Permobil received a certified letter from end-user's legal representative reporting they have been retained by the end-user to represent on his behalf regarding an alleged undisclosed injury that was sustained by the end-user because of a non-specific malfunction of the chair.The letter indicated the injuries were sustained sometime in 2017 but did not give a definitive date.In effort to gather a more defined understanding as to the allegations, permobil legal counsel contacted client counsel to inquire further.It was reported the tilt function on the device had become inoperable which led to the inability to change position for pressure relief.End-user alleged this caused an infection to occur in their leg which led to the need amputate the right leg below the knee.Due to litigation, permobil has not been permitted to inspect the device to confirm the allegation of failure and end-user's legal counsel is not being forthcoming.The dhr was reviewed and device met specification prior to distribution.If more information is received, a follow-up report will be submitted.

Event Description

Received notice of end-user alleging the tilt function of the device had become inoperable which led to the end-user having contracted an infection in their leg requiring medical intervention.

• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 7561327
• MDR Text Key: 109829544
• Report Number: 1221084-2018-00036
• 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: Attorney
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• 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: 118