|
Model Number 31628 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
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.
|
|
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 pain, adhesions, and an intense fibrotic reaction/infection.Plaintiff had to undergo additional surgeries.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
|
Additional information: age/date of birth, describe event or problem, relevant tests/laboratory data, other relevant history, model #/lot #, device manufacture and evaluation codes.Investigation: 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.
|
|
Event Description
|
Plaintiff allegedly also experienced blood loss incarceration, inflammation, cellulitis, seroma, incision and drainage.
|
|
Search Alerts/Recalls
|
|
|