Model Number 31233 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240)
|
Event Date 08/22/2012 |
Event Type
Injury
|
Event Description
|
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical mesh product.It was alleged that the mesh was explanted because of pain, recurrent incision hernia and adhesions.Since this is a potential 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 supplemental this report as appropriate if additional info comes to its attention.
|
|
Manufacturer Narrative
|
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.A review of the medical record provided was completed.The records indicate the pt had a history of a gastric tumor excision and had developed an incisional hernia.At the time of the implant adhesions were found of the intestine and omentum.
|
|
Manufacturer Narrative
|
A review of the manufacturing lot history and sterilization records was conducted.The release criteria was met.
|
|
Event Description
|
Cultures taken at the time of removal show no evidence of infection.
|
|
Manufacturer Narrative
|
A follow up report will be submitted upon the completion of the investigation into this event.
|
|
Search Alerts/Recalls
|