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AMPatch Stoma Cover

Austin Medical Products, Inc. · Model LNR with 1 1/8" Hole · UDI-DI 00838234002145

EXE Prescription

510(k) clearances

32,272

Adverse events (1 deaths)

Recalls

Facilities

Description

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.

Recalls

Date	Firm	Reason
2024-11-29	ConvaTec, Inc	Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot
2024-08-08	T.G. Eakin Limited	On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
2022-04-22	ConvaTec, Inc	Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
2019-09-06	ConvaTec, Inc	ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017

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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.