C-QUR 31531Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00650862315318), received between Apr 18, 2020 and Nov 20, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Output Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K050311, K151386); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED THE PLAINTIFF ALSO ALLEGEDLY EXPERIENCED 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.

  Patient problems: Adhesion(s); Hernia; Pain; Skin Inflammation/ Irritation

  MAUDE report 20741578 ↗
• InjurySep 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 BOWEL OBSTRUCTION, SMALL BOWEL REPAIR, PAIN, NAUSEA, ABSCESS, ENTEROTOMY, WOUND DEHISCENCE, ADHESIONS, LYSIS OF ADHESIONS, WOUND DEBRIDEMENT, WOUND VAC, MULTIPLE REVISION SURGERIES 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.

  Patient problems: Adhesion(s); Obstruction/Occlusion; Unspecified Infection

  MAUDE report 20233462 ↗
• InjuryJan 13, 2022Output Problem

  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 GROIN PAIN, DENSE ADHESIONS AND RECURRENT HERNIA. 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.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 13250153 ↗
• InjuryApr 18, 2020Adverse Event Without Identified Device or Use Problem

  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 ALSO ALLEGEDLY EXPERIENCED ADDITIONAL SURGERY AND/ OR IMPLANTATION OF ADDITIONAL MESH, ABDOMINAL PAIN, EMOTIONAL DISTRESS, POST-SURGICAL PAIN AND SUFFERING. 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.

  Patient problems: Adhesion(s)

  MAUDE report 9975720 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050311, K151386. One submission often covers many models, so check the product and lot details in each record.

• Z-1936-2013 · Jul 19, 2013 · Terminated
  C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
• Z-1937-2013 · Jul 19, 2013 · Terminated
  C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.