|
Model Number 31531 |
Device Problems
Appropriate Term/Code Not Available (3191); Material Split, Cut or Torn (4008)
|
Patient Problems
Ecchymosis (1818); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Hernia (2240)
|
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 mesh partially torn, multiple revision surgeries (b)(6) 2011, infection, folded and balled up mesh, scarring, adhesions, hernia recurrence, abscess, and chronic 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 allegedly also experienced abdominal wall hematoma, fluid collection, ecchymosis, debridement, chronically draining wound, purulent material and chronic granulation tissue, sinus tract, chronic fibrous tissue.
|
|
Manufacturer Narrative
|
Additional information section: a2, b5, b7, d4, h4, h6.Corrected information section: d7.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
|
|
|