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Repose Mattress Overlay

Frontier Therapeutics Inc · Model 6011100 · UDI-DI 05056279301152

IKY

510(k) clearances

1,577

Adverse events (35 deaths)

Recalls

158

Facilities

Description

Repose Mattress Overlay is designed for use on a standard single mattress, where it is proven to provide effective pressure redistribution. Suitable for use in both acute and community settings, Repose Mattress Overlay comes packaged inside a unique and easy to use pump, which enables the mattress overlay to be inflated ready for use within seconds, and the smart valve ensures that the product is inflated to the optimal pressure.

Recalls

Date	Firm	Reason
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-04-19	EHOB, Inc.	Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
2020-08-12	Stryker Medical Division of Stryker Corporation	Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients exper
2020-01-19	EHOB, Inc.	Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- contro
2018-05-03	Joerns Healthcare	Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresse
2018-05-03	Joerns Healthcare	Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresse
2014-09-01	Arjo Hospital Equipment AB	The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
2011-04-29	Stryker Medical Division of Stryker Corporation	Affected mattresses may not conform to federal flammability standards.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.