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SenSura Mio
Coloplast A/S · Model 13665 · UDI-DI 05701780240925
10
510(k) clearances
543
Adverse events (2 deaths)
5
Recalls
88
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-07-27 | Coloplast Manufacturing US, LLC | On 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 |
| 2011-06-22 | Convatec Inc. | Post-operative kits 57 mm may contain 70 mm pouches. |
| 2011-02-01 | Convatec 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 |
| 2008-03-07 | ConvaTec | Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure." |
| 2008-02-14 | ConvaTec | Mislabeled: 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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Get your free API keyRead the docsData 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.