|
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060)
|
Event Type
Injury
|
Manufacturer Narrative
|
We are unable to fully investigate this event as no product code, lot number, or sample was provided.
|
|
Event Description
|
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 medicals mesh product.Plaintiff allegedly experienced pain, emotional injuries without treatment, infection, additional surgery and adhesions.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.
|
|
Event Description
|
Plaintiff also allegedly experienced drainage, erythema, scar tissue, incarceration and component separation.
|
|
Search Alerts/Recalls
|
|
|