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 surgical revision, adhesions, bowel obstruction, infection, improper healing inadequate or failure of incorporation/ingrowth, chronic pain, recurrence of hernia, foreign body response, rejection, mesh migration, excessive and chronic inflammation, scarification, granulomatous response, allergic reaction, erosion, abscess, fistula, seroma, nerve damage, tissue damage, and emotional distress.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.
|
Additional information section: a2, b5, b7, d4, h4, h6.Based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirements.
|