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MedibinoNEO ring – TG PUR Gel - Size L - PU 6

Kluba Medical GmbH · Model 1 · UDI-DI 04260764840557

FMP FRP PRN

510(k) clearances

239

Adverse events (7 deaths)

Recalls

383

Facilities

Description

Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.

Recalls

Date	Firm	Reason
2020-06-09	EHOB, Inc.	QC inspection observed that a portion of the lot may have been contaminated with blood.
2015-12-01	3M Company - Health Care Business	Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex
2014-10-10	Philips Medical Systems, Inc.	Mold on gel filled Gel-E and Squishon products
2014-05-28	Childrens Medical Ventures	The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fu

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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.