C-QUR 31537Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862315370), received between Jun 10, 2016 and Apr 2, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 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 LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED INFECTION, CHRONIC OPEN WOUND, PURULENT DRAINAGE, EXPOSED, LYSIS OF ADHESIONS, UNINCORPORATED MESH, NON-HEALING WOUND, INFLAMMATION AND ADDITIONAL SURGERY. 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: Hernia; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 19029788 ↗
• InjuryMay 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 EXPOSED AND UNINCORPORATED MESH. 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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 16981676 ↗
• InjuryDec 6, 2022Adverse 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 ALLEGEDLY EXPERIENCED PAIN, ABSCESS, ADHESIONS, FISTULA, INFECTION, BOWEL RESECTION, ADDITIONAL SURGERY. 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: Abscess; Adhesion(s); Pain

  MAUDE report 15923523 ↗
• InjuryDec 4, 2022Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 PAIN, EXTENSIVE ADHESIONS, SMALL BOWEL RESECTION, INFECTION, ABSCESS, FISTULA AND ADDITIONAL SURGERY. 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: Abscess; Adhesion(s); Fistula

  MAUDE report 15912514 ↗
• InjuryOct 7, 2019Patient-Device Incompatibility

  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 RECURRENCE, INCARCERATION, COMPONENT SEPARATION, EVISCERATION, DEBRIDEMENT, SEROMA, PURULENT FLUID AND ADHESIONS. 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; Seroma

  MAUDE report 9161151 ↗
• InjuryMay 24, 2019Use of Device Problem; Use of Device Problem

  RECEIVED MEDWATCH MW5086035 THAT STATES "THIS MESH WAS IDENTIFIED AS A PROBLEM AS A RETAINED SURGICAL ITEM". THE MESH WAS TRIMMED AND THE CLEAR, COLORLESS, SHINY PORTION OF THE SLEEVE WAS NO LONGER DISTINGUISHABLE FROM THE COATED SURFACE OF THE MESH. THE ABSENCE OF COLOR OR MARKINGS ON THE SLEEVE ALLOWED THE PORTION OF THE SLEEVE STILL CLINGING TO THE MESH TO BE IMPLANTED WITHOUT DETECTION. THE PATIENT WAS ALREADY IN RECOVERY BY THE TIME THE ERROR WAS REALIZED BY A SURGICAL TECH. THE PATIENT HAD TO BE RE-INTUBATED AND HAD TO GO BACK UNDER ANESTHESIA AND RE-OPENED TO OBTAIN THE MESH BACKING.

  Patient problems: Foreign Body In Patient

  MAUDE report 8642490 ↗
• InjuryOct 23, 2018Appropriate Device Problem Term/Code Not Available

  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 RECURRENT INCISIONAL HERNIA REQUIRING PLACEMENT OF NEW MESH FOR REPAIR, LYSIS OF ADHESIONS, SHRINKING AND ROLLING OF C-QUR MESH, BOWEL OF JEJUNUM ADHERENT TO MESH AND PAIN. 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 7994319 ↗
• InjuryJun 10, 2016Insufficient Device Problem Information

  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 MEDICALS MESH PRODUCT. ALLEGEDLY PLAINTIFF DEVELOPED SEROMA AFTER THE MESH WAS IMPLANTED FOR REPAIR OF A SYMPTOMATIC INCISIONAL 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); Inflammation; Seroma; Unspecified Infection

  MAUDE report 5718943 ↗

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.