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H&H

TRONJEN MEDICAL TECHNOLOGY INC. · Model HW0505 · UDI-DI 04719859641925

NAE

510(k) clearances

105

Adverse events

Recalls

304

Facilities

Description

Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with wound healing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’s figure perfectly, patients feel comfortable in their daily movements)

Recalls

Date	Firm	Reason
2020-02-11	Nelson Innovaions, Llc	Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
2018-08-22	Safe N Simple, LLC	The sterilization process used was unqualified.
2018-08-22	Safe N Simple, LLC	The sterilization process used was unqualified.
2016-09-01	CellEra LLC	Adhesive border was not sticky enough.
2015-09-30	O-Two Medical Technologies, Inc.	For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches o
2006-11-09	Embeem Inc.	Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material

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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.