C-QUR 31507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862315073), received between Jan 11, 2017 and Aug 16, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 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 ALLEGEDLY EXPERIENCED ADHESIONS, SCARRING, SHRINKING OF MESH, RECURRENT HERNIA, MESH FAILURE AND REMOVAL. 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

  MAUDE report 8903223 ↗
• InjuryJan 11, 2017Appropriate Device Problem Term/Code Not Available

  FOLLOWING SURGERY FOR HERNIA REPAIR, MESH WAS EXPLANTED DUE TO RECURRENCE. NO INFECTION WAS NOTED BUT A LARGE INFLAMMATORY RESPONSE WAS SEEN. PATIENT WAS TESTED FOR INFECTION BUT NONE FOUND.

  Patient problems: Inflammation

  MAUDE report 6240276 ↗

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.