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

Model Number	31201
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Hernia (2240); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.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 was implanted with an c-qur v-patch mesh.Plaintiff allegedly experienced small-bowel erosion fistula, infection, adhesions, abscess, small bowel resection, additional surgery (b)(6) 2022, bowel volvulus and obstruction, scar tissue.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 V-PATCH
• 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: 22561634
• Report Number: 3011175548-2025-000008
• Device Sequence Number: 19786096
• Product Code: FTL
• UDI-Device Identifier: 00650862312010
• UDI-Public: (01)00650862312010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 07/18/2025

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 Model Number: 31201
• Device Catalogue Number: 31201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71 YR
• Patient Sex: Male