This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable events may have occurred during use of atrium medicals mesh product.Plaintiff alleges that after hernia surgery and mesh implantation a pt had recurrent incisional hernia.It was also alleged that later the pt developed other issues, had other surgeries and expired.Since this is a legal matter, the case has been turned over to legal counsel and further info 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 add'l info comes to its attention.
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A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.This report is based upon allegations made in a lawsuit in which atrium medical is named defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit and described herein are or were defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.
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