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Blue Diamond

David Scott Company · Model BD2510 · UDI-DI 15060797552016

FMP

510(k) clearances

232

Adverse events (7 deaths)

Recalls

381

Facilities

Description

Blue Diamond® Flat Bottom Chest Roll. These viscoelastic polymer gel pads have a thin thermoformed skin and simulate human adipose tissue. They are a versatile roll used for axillary, shoulders, chest distensions, under knees, as well as bolster rolls to keep patients in place. A wide variety of shaped & sizes are available. This particular one is more dome shaped.

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.