This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced severe abdominal pain, pain, discomfort, and tenderness, seroma, infection, failure to incorporate, additional surgery, mental anguish, severe emotional distress, permanent and severe scarring and disfigurement.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.
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Plaintiff allegedly also experienced fibrosis, sinus tract, granulation tissue, inflammation, purulent drainage, and giant cell reaction.
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