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

Model Number	31540
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bowel Burn (1756); Pain (1994); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirement.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.
Event or Problem Description
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product.Plaintiff allegedly experienced abdominal pain, strangled bowel, small bowel resection, loops of bowel, rectus diastasis, vomiting, incarcerated, bowel obstruction, edema, hemorrhage, scarring, hematoma, adhesions, lysis of adhesions, serosal tears, calcified & non-calcified fibroids tissue and additional hospital stay on (b)(6) 2023.Since this is a potential 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.
Additional Manufacturer Narrative
Additional information section: b5, e1 & h6.Based on the additional information received the plaintiff alleged infection, therefore a review of the sterilization records was performed and found to have met all specifications.
Event or Problem Description
Additional information received the plaintiff also 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, erosion, abscess, fistula, granulomatous response, seroma formation, and tissue damage.

• Brand Name: MESH C-QUR
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 20733650
• Report Number: 3011175548-2024-000024
• Device Sequence Number: 21056286
• Product Code: FTL
• UDI-Device Identifier: 00650862315400
• UDI-Public: (01)00650862315400(17)160130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 31540
• Device Catalogue Number: 31540
• Device Lot Number: 10871234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 117 KG