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Blue Diamond

David Scott Company · Model BD0100-2580 · UDI-DI 15060797551071

FMP

510(k) clearances

234

Adverse events (7 deaths)

Recalls

382

Facilities

Description

This Blue Diamond® Gel Pad is a pressure management pad. All our gel pads are made in the USA and are designed to mimic human adipose tissue composition to help prolong the chance of pressure insults. Because of the size of this pad it is ideal for Gel Wrap for 6" Peg Board Posts. 5" x 7" x 3/8" with Velcro® closures.

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.