|
Model Number 31201 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930)
|
Event Type
Injury
|
Manufacturer Narrative
|
We are unable to fully investigate this event as no product code, lot number, or sample was provided.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.Device evaluated by manufacturer: 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 infection, dense adhesions and tears.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
|
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.H3 other text : not available for return.
|
|
Event Description
|
Plaintiff also allegedly experienced enterotomies, bilateral component separation, debridement, small bowel resection, abdominal wall reconstruction and wound vac drainage.
|
|
Search Alerts/Recalls
|
|
|