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

Device Problems Contamination (1120); Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Abdominal Pain (1685); Abscess (1690); Abscess (1690); Adhesion(s) (1695); Adhesion(s) (1695); Erosion (1750); Erosion (1750); Emotional Changes (1831); Emotional Changes (1831); Fistula (1862); Fistula (1862); Foreign Body Reaction (1868); Foreign Body Reaction (1868); Inflammation (1932); Inflammation (1932); Nerve Damage (1979); Nerve Damage (1979); Scarring (2061); Seroma (2069); Seroma (2069); Tissue Damage (2104); Tissue Damage (2104); Hernia (2240); Hernia (2240); Impaired Healing (2378); Impaired Healing (2378); Reaction (2414); Reaction (2414); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Post Operative Wound Infection (2446); Blood Loss (2597)

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 removal of infected mesh, removal of adhesions, bowel obstruction, abdominal pain, wound infection, improper healing inadequate or failure of incorporation/ingrowth, chronic pain, recurrence of hernia, foreign body response, rejection, mesh migration, excessive and chronic inflammation, scarification, granulomatous response, allergic reaction, adhesions to internal organs, erosion, abscess, fistula formation, seroma formation, nerve damage, tissue damage and emotional distress.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.

Event Description

Plaintiff also allegedly experienced unincorporated mesh and blood loss.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8409340
• MDR Text Key: 138435923
• Report Number: 3011175548-2019-00242
• Device Sequence Number: 0
• Product Code: FTL
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/11/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention