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Brava
Coloplast A/S · Model 120610 · UDI-DI 05708932750189
3
510(k) clearances
91
Adverse events (6 deaths)
6
Recalls
146
Facilities
Description
Brava Lubricating Deodorant / Brava / Brava Protective Sheet / Brava Odor neutralizer. Multi-lubricating effect. 1. Shake the bottle well before use. 2. Add 5-10 ml in the bag and rub the bag gently to spread Brava Lubricating Deodorant evenly. If you use an open bag you can also add the deodorant through the outlet. 3. Repeat after emptying the bag.. Mandatory text BR 1. Ostomy Care. Volume 240 ml.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-30 | MEDLINE INDUSTRIES INC | Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold. |
| 2012-06-18 | Safe N Simple, LLC | The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of in |
| 2011-05-31 | BioDerm, Inc. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male |
| 2011-05-31 | BioDerm, Inc. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male |
| 2011-05-31 | BioDerm, Inc. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Cl |
| 2011-04-04 | Smith & Nephew Inc. | Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SK |
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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.