MAUDE Adverse Event Report: PERMOBIL AB (PAB) F5 CORPUS VS; POWERED WHEELCHAIR

Model Number F5 CORPUS VS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); Swelling/ Edema (4577)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Permobil representatives evaluated the device and confirmed, through functional testing, that the device met specification and were unable to identify any malfunction having occurred which may have contributed to this reported incident.Evaluation of the device concluded no product malfunction or deviation in operation having occurred leaving permobil unable to establish or confirm a potential root cause for this reported event.It should be noted the device was a demo being used for the purpose of evaluation and was not prescribed for this specific client.Although unconfirmed, it is possible the root cause for this event to have been improper positioning of the knee block support.The knee block support being adjusted too high could apply excessive pressure to the end-user's patella when their body weight was applied during a stand function.This potential was brought to the service providers attention w/recommendation that a therapist be present to ensure proper positioning is achieved prior to standing evaluations.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Permobil ab received report claiming during an evaluation of the standing seating function of the device, the end-user claimed having received a pain in their right knee, later that evening noted some bruising and swelling.A physician diagnosed the injury as consisting of soft tissue and ligament damage.

• Brand Name: F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86102 3; SW 861023
• Manufacturer (Section G): PERMOBIL AB; per uddens vag 20; timra, 861 2 3; SW 861 23
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 11181699
• MDR Text Key: 230314674
• Report Number: 1221084-2021-00001
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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