|
Model Number 31201 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
We are unable to fully investigate this event as no product code, lot number, or sample was provided.Not returned.
|
|
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 medical¿s mesh product.Plaintiff allegedly experienced abscess, infection, sinus tract, local and systemic inflammatory response, seroma and abdominal pain.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 draining wound, erythema, adhesions, debridement, granulated tissue and scar tissue.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|