MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Scarring (2061); Seroma (2069); Tissue Damage (2104); No Code Available (3191)

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 chronic pain, recurrence of hernia, foreign body response, rejection, infection, failure of incorporation/ingrowth, scarification, improper wound healing, excessive and chronic inflammation, allergic reaction, adhesions to internal organs, erosion, abscess, fistula, granulomatous response, seroma formation and tissue damage.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.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7826651
• MDR Text Key: 118563063
• Report Number: 3011175548-2018-00950
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR