MAUDE Adverse Event Report: INVACARE TAYLOR STREET CONTOURU CUSHION; CUSHION, WHEELCHAIR

Model Number CM02S

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

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

This event is being reported to the fda in an abundance of caution due to the allegation that the patient developed pressure sores while using the cushion, which required medical intervention by a health care professional to preclude death or serious injury.However, the cushion is only one of many potential contributing factors of the patient developing sores.Pressure sores are injuries to skin and underlying tissue resulting from pressure on the skin when resting in a position for an extended period and can occur regardless of the resting surface being used.Development of pressure sores is multi-factorial.In addition to pressure, primary external causes include friction and shear.Individual risk factors also play a key role in increasing the patient's susceptibility; examples include, but are not limited to: patient size, weight, immobility, lack of sensory perception, incontinence, medical conditions affecting blood flow, poor nutrition, and poor hydration.The management, treatment and prevention of pressure sores should be individualized and depends on the patient¿s medical history, risk factors and physical status.In all cases, care is pivotal in pressure sore prevention.Education, clinical judgement, and action-based planning based on vulnerability are fundamental factors in the prevention and treatment of pressure sores.It is very important for the patient to reposition themselves, or to be repositioned, on a regular basis.It is the standard of care that the patient¿s condition should be monitored frequently, and their individualized care plan should be reviewed regularly by caregivers, adjusting for changes in the patient¿s condition and environmental factors.There was no alleged deficiency/malfunction with the cushion.The contouru cushions are customized for each individual user using the patient's unique shape.The process may require some trial-and-error in order to find the best fit for the patient.Changes to the cushion may also be required as the patient's needs change.The cushion was made according to the specifications provided and has been in use for seven months; it is just no longer a good fit for the patient.A replacement cushion is being made with modifications to better fit the patient.

Event Description

The dealer alleged that the curvature of the adductors on the contouru seat cushion are rubbing on the patient's leg, and the patient has sustained pressure sores which have intensified and now require professional care.

• Brand Name: CONTOURU CUSHION
• Type of Device: CUSHION, WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 10374952
• MDR Text Key: 202011469
• Report Number: 1525712-2020-00019
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CM02S
• Device Catalogue Number: CM02S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention