MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-05 for CONTOURU CUSHION CM02S manufactured by Invacare Taylor Street.
[178339254]
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.
Patient Sequence No: 1, Text Type: N, H10
[178339255]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2020-00008 |
| MDR Report Key | 9671389 |
| Report Source | OTHER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOURU CUSHION |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2020-02-05 |
| Model Number | CM02S |
| Catalog Number | CM02S |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |