|
Model Number 31128 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
|
Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Seroma (2069); 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 hernia recurrence, severe and chronic 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.
|
|
Manufacturer Narrative
|
Correction section: a3, d7 additional information section: a2, b5, b7, d4, h4, h6.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 also allegedly experienced seroma, adhesions, infection and scar tissue, mesh contraction, per medical records received, ¿by the patient¿s own admission, he did too much activity too early and had a recurrence of his hernia.
|
|
Search Alerts/Recalls
|
|
|