MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5 CORPUS VS; POWERED WHEELCHAIR

Model Number F5 CORPUS VS

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Too Soft/Flexible (4007)

Patient Problems Pressure Sores (2326); Tissue Breakdown (2681)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

A permobil representative had received a report of an end-user who had come to a scheduled appointment at a local wound care clinic in (b)(6) of 2019.Reports claim when the user arrived, the therapist noticed a wetness permeating through the end-user's left pant leg.Upon lifting the garment to inspect, they noted seeing a severe wound on the upper portion of their left tibia.The therapist described the wound as being a stage 4 pressure ulcer.Reports provided claim the most logical cause for this ulcer was the pressure induced to the leg, by the knee block assembly, when the end-user utilized the stand function of their device.The therapist described the pad as being very worn and thin to where it was no longer providing any further cushioning.Reports claim the end-user was instructed to refrain from using the stand feature any further until his wound could heal and appropriate padding can be ordered and installed to better support his physical needs.The therapist reported having seen the end-user multiple times since initial awareness and claims the end-user's wound had completely healed approximately 3-4 weeks afterwards.Records confirm an order having been placed for custom knee block inserts at the timeframe this event was reported to have occurred, but permobil was not made aware at that time that an injury had occurred.Due to the 2-year timespan from the occurrence to when permobil was notified, an inspection of the original knee pads could not be performed as they were disposed of, therefore permobil is unable to reach a determination as to possible root cause without speculation.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Received report claiming the end-user came into a follow up clinic appointment and was found to have a significant pressure injury on their left lower extremity, which was reportedly caused by lack of padding in the knee supports on the standing power wheelchair.

• Brand Name: PERMOBIL F5 CORPUS VS
• 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: 12005183
• MDR Text Key: 256799109
• Report Number: 1221084-2021-00022
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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): Other; Required Intervention