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SenSura Click

Coloplast A/S · Model 10045 · UDI-DI 05708932408691

EXB
10
510(k) clearances
550
Adverse events (2 deaths)
5
Recalls
88
Facilities

Description

SenSura Click / SenSura Click Click Xpro ostomy baseplate / Coloplast / Coloplast Click Xpro ostomy baseplate / SenSura Click SenSura Click Xpro ostomy baseplate / Coloplast SenSura Click Xpro ostomy baseplate / SenSura Product name: 2-piece Ostomy bag / SenSura Click Xpro ostomy baseplate. With belt ears. Not for individual sale. Registered trademark phrase for Mexico. Maxi. Coupling Size Diameter 70 mm, Coupling Size Diameter 2 3/4 in, Base Plate Precut Start Hole Size 10 mm, Base Plate Max Cut Size 65 mm, Baseplate Max Cut Size 2 9/16 in, Baseplate Precut Start Hole Size 3/8 in, Base Plate Type Flat.

Recalls

DateFirmReason
2011-07-27Coloplast Manufacturing US, LLCOn July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these results it was determine
2011-06-22Convatec Inc.Post-operative kits 57 mm may contain 70 mm pouches.
2011-02-01Convatec Inc.Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter
2008-03-07ConvaTecMislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."
2008-02-14ConvaTecMislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.

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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.