|
Model Number 31536 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Information (3190)
|
Event Date 09/17/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
A follow up report will be submitted upon the completion of the investigation into this event.
|
|
Event Description
|
This event is deemed reportable based on the allegations in a pre-suit claim which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Claimant attributes unspecified complications to the mesh.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.
|
|
Manufacturer Narrative
|
A review of all manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile packaging.Ball burst and suture retention testing was also conducted on the mesh at incoming and fourier transform infrared spectroscopy was performed on the cured coated mesh panels.
|
|
Event Description
|
This report is deemed reportable based on the allegations in a lawsuit claim which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Allegedly, plaintiff had protrusion of abdominal contents in her lower abdomen and a computed tomography scan revealed a nonspecific fluid collection around her c-qur mesh.Allegedly an emergency exploratory laparotomy was performed to remove the infected mesh and as soon as her abdominal area was opened, purulent fluid had to be drained from around the mesh.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.
|
|
Search Alerts/Recalls
|
|
|