C-QUR 31540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00650862315400), received between Jul 26, 2016 and Nov 20, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 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.

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

  MAUDE report 20733650 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PLAINTIFF'S ALLEGEDLY ALSO EXPERIENCED PAIN, FISTULA, HERNIA RECURRENCE, CELLULITIS, NON-INCORPORATED AND INCORPORATED MESH, EMOTIONAL INJURY, RESECTION OF DRAINING SINUS, FAILED ANTIBIOTIC THERAPY, DEBRIDEMENT, FLUID COLLECTION AND DRAINAGE.

  Patient problems: Abscess; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 20652722 ↗
• InjurySep 17, 2021Adverse 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 RECURRENCE, ADHESIONS, PAINFUL 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: Adhesion(s); Hernia

  MAUDE report 12493016 ↗
• InjuryOct 5, 2020Appropriate 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 RECURRENT ABDOMINAL WALL FLUID COLLECTION ASSOCIATED WITH MESH-NEEDLE ASPIRATION. 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: Seroma

  MAUDE report 10632377 ↗
• InjuryDec 6, 2016Contamination; Device Contamination With Biological Material; Device Operates Differently Than Expected

  PATIENT WITH VENTRAL HERNIA IN WHICH A MESH DID NOT INTEGRATE. THE PATIENT DEVELOPED WOUND INFECTION EIGHT WEEKS AFTER SURGERY AND THE MESH WAS REMOVED. CULTURES SHOWED ENTEROBACTERIACEAE STAPHYLOCOCCUS. ANTIBIOTICS WERE GIVEN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6148626 ↗
• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A PRE-SUIT CLAIM WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICALS MESH PRODUCT. CLAIMANT ATTRIBUTES UNSPECIFIED COMPLICATIONS TO THE 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: Complaint, Ill-Defined; Hernia; Inflammation

  MAUDE report 5821644 ↗

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