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 hernia recurrence, mesh shrinkage, mesh disruption, infection, cellulitis/ abscess, chronic sinus tract, mesh exposure and bowel exposure, non-healing wound, debridement, sinus tract, adhesions, granulation.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.
|