This event is being reported to the fda in an abundance of caution due to the allegation that the patient developed a pressure sore while using the cushions, which required medical intervention by a health care professional to preclude death or serious injury.However, the cushions are only one of many potential contributing factors of the patient developing the sore.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 cushions.They were made according to the specifications provided; they just did not suit the patient's needs.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.The provider stated that the cushions were delivered mid september 2019 and were used almost 3 months before the patient reported the pressure sore.The provider advised that the patient previously had pressure sores, which is why the cushions were ordered in the first place.The patient's shape has been recaptured and new cushions will be made with different specifications to alleviate the pressure area.
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The provider reported that when they delivered the contouru cushions to the patient, the fit seemed to be okay, but now the patient has developed a stage 3 pressure sore on her back, which is being treated with ointment.
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